Table of Contents

Examples for ordering ....................................................................................... 9

Dissolution

Dissolution Testers (USP apparatus 1, 2, 5 and 6)

ERWEKA DT 820 6, 7 and 8 stirrer type, 1000 ml versions ...............................................10
ERWEKA DT 826 ............................................................................................................. 11
ERWEKA DT 827 ............................................................................................................. 11
ERWEKA DT 828 ............................................................................................................. 11
Options ............................................................................................................................. 12
Spare part kits ................................................................................................................. 13
ERWEKA DT 720 6, 7 and 8 stirrer type, 1000 ml and 4000 ml versions .................................14
ERWEKA DT 726 ............................................................................................................. 15
ERWEKA DT 727 ............................................................................................................. 15
ERWEKA DT 728 ............................................................................................................. 15
Options ............................................................................................................................. 16
Spare part kits ................................................................................................................. 17
ERWEKA DT 720 R 6 and 7 stirrer type, 1000 version...................................................18
ERWEKA DT 726 R ......................................................................................................... 19
ERWEKA DT 727 R ......................................................................................................... 19
Options ............................................................................................................................. 20
Spare part kits ................................................................................................................. 20
ERWEKA DT 720 - 4000 6 and 7 stirrer type, 4000 ml version ........................................21
ERWEKA DT 726 HH - 4000............................................................................................ 21
ERWEKA DT 727 HH - 4000............................................................................................ 21
Options ............................................................................................................................. 22
Spare part kits ................................................................................................................. 22
ERWEKA DT 1420 12, 13 and 14 stirrer type, 1000 ml version ..........................................23
ERWEKA DT 14212 ......................................................................................................... 24
ERWEKA DT 14213 ......................................................................................................... 24
ERWEKA DT 14214 ......................................................................................................... 24
Options ............................................................................................................................. 25
Spare part kits ................................................................................................................. 25
ERWEKA DT 620 High-Head 6 stirrer type, 1000 ml and 2000 ml version .........................26
ERWEKA DT 626 HH ....................................................................................................... 26
ERWEKA DT 626-2000 .................................................................................................... 26
Options ............................................................................................................................. 27
Spare part kit .................................................................................................................... 27
Components .................................................................................................28
IPC 8 ................................................................................................................................. 28
IPC 16............................................................................................................................... 28
SP 725/10 ......................................................................................................................... 29
SP 725/25 ......................................................................................................................... 29
PVP 720 ........................................................................................................................... 30
FRL 720 ............................................................................................................................ 31
FRL 724 ............................................................................................................................ 32
Options ............................................................................................................................. 33
AFC 825 ........................................................................................................................... 33
AMC-A .............................................................................................................................. 34

1
Dissolution Offline Kits
Budget Kit ....................................................................................................36
Base Kit ........................................................................................................37
Precision/lq Kit.............................................................................................39
Precision/hq Kit ...........................................................................................41
Fast Kit .........................................................................................................43
Power Kit ......................................................................................................45
Base-14 Kit ...................................................................................................47
Fast-14 Kit ....................................................................................................49
Power-14 Kit .................................................................................................51
Dual Kit .........................................................................................................53
Dissolution Systems
UV-VIS In- or Online System (analysis only) .......................................................55
1. Sample transfer pump .................................................................................................. 55
1.1. ERWEKA IPC 8
1.2. Agilent sample transfer pump
2. UV-VIS Spectrophotometers ........................................................................................ 55
3. System control .............................................................................................................. 56
3.1. Windows Dissolution software
3.2. Driver for Agilent 8453
4. System tubing ............................................................................................................... 56
5. System pre-configuration ............................................................................................. 56
6. Computer ...................................................................................................................... 56
Options ............................................................................................................................. 57
UV-VIS Dual Online Systems (analysis for 2 independent DT's) ..................................58
1. 2x Sample transfer pump, IPC 8 .................................................................................. 58
2. UV-VIS Spectrophotometers ........................................................................................ 58
3. System control .............................................................................................................. 58
4. System tubing ............................................................................................................... 58
5. System pre-configuration ............................................................................................. 59
6. Computer ...................................................................................................................... 59
Options ............................................................................................................................. 59
UV-VIS Off-/Online Systems (storage, media replacement, dilution,UV-VIS analysis) .............60
1. Sample transfer pump, SP 825/25 (Syringe Pump) ..................................................... 60
2. Autosampler, FRL 820 ................................................................................................. 60
3. UV-VIS Spectrophotometers ........................................................................................ 61
4. System control .............................................................................................................. 61
5. System tubing ............................................................................................................... 61
6. System pre-configuration ............................................................................................. 61
7. Computer ...................................................................................................................... 62
Options ............................................................................................................................. 62
Half Automated Dissolution System HADs ...............................................63
1. Dissolution Tester/s ...................................................................................................... 64
2. Options ......................................................................................................................... 64
3. Video Monitoring/ Recording ........................................................................................ 65
4. Filtration ........................................................................................................................ 65
5. Sample Transfer Pump ................................................................................................ 65
6. HADs-HPLC/UV-VIS-Module ....................................................................................... 65

2
RoboDis
RoboDis ........................................................................................................67
1. Base Unit ...................................................................................................................... 68
2. Options ......................................................................................................................... 68
3. Extensions .................................................................................................................... 69
4. Basket Handling Module .............................................................................................. 69
Analytical Modules ......................................................................................70
Fibre Optics UV-VIS Online.............................................................................................. 70

Dissolution Accessories
Vessels for Dissolution ...............................................................................71
Plastics ............................................................................................................................. 71
Glass ................................................................................................................................ 71
UV-resistant glass ............................................................................................................ 71
Conversion Kit for 250 ml vessel ...................................................................................... 71
Stirring Elements for Magni/UniShaft System...........................................72
Basket Holders ................................................................................................................. 72
Baskets ............................................................................................................................. 73
Paddles and Discs USP apparatus 2 and 5 ...............................................74
Paddle Magni/UniShaft ..................................................................................................... 74
Paddle over Disc Magni/UniShaft .................................................................................... 75
Rotating Cylinders USP apparatus 6 UniShaft ..........................................75
Enhancer Cell ................................................................................................................... 76
Extraction Cell .................................................................................................................. 76
Felodipine Basket ............................................................................................................. 76
Instrinsic Dissolution (Wood Apparatus) .......................................................................... 76
Filters for manual and automated sampling .............................................77
Manual sampling manifold ..........................................................................77
Sinkers..........................................................................................................78
Tubing and Connectors ..............................................................................78
Qualification .................................................................................................79
Qualification documents for Dissolution Testers and Dissolution Systems ..................... 79
USP Reference Standards ............................................................................................... 79
Qualification tools for Dissolution Testers ....................................................................................... 79

Dissolution Testers (USP apparatus 3 and optional 7)

CALEVA BioDis RRT 10 ..............................................................................80
Dissolution Testers (USP apparatus 4)
ERWEKA DFZ 720 and HKP 720 .................................................................82
Options ............................................................................................................................. 83

Dissolution System (Open-Loop Offline)

ERWEKA Dissolution Offline Systems ......................................................85
1. Autosampler ................................................................................................................. 85
2. System control .............................................................................................................. 85
3. System pre-configuration ............................................................................................. 85
4. System tubing ............................................................................................................... 85
5. Options ......................................................................................................................... 86

3
Dissolution System (Closed-Loop Offline)
ERWEKA Dissolution Offline Systems ......................................................87
1. Autosampler ................................................................................................................. 87
2. System control ............................................................................................................. 87
3. Peristaltic Pump ........................................................................................................... 87
4. System pre-configuration ............................................................................................. 87
5. System tubing ............................................................................................................... 87
6. LMT .............................................................................................................................. 88
7. Options ......................................................................................................................... 88

Dissolution System (Closed-Loop UV-VIS Online Kit)

ERWEKA Dissolution Online Systems ......................................................89
1. UV-VIS Spectrophotometer .......................................................................................... 89
2. Dissolution system software ........................................................................................ 89
3. System tubing ............................................................................................................... 89
4. System pre-configuration ............................................................................................. 89
5. LMT .............................................................................................................................. 89
6. Peristaltic Pump ........................................................................................................... 89
7. Options ......................................................................................................................... 90

Dissolution Media Preparation and Dosing

MediPrep 120 ................................................................................................................... 91
MediaTank ........................................................................................................................ 91
MultiPrep .......................................................................................................................... 92

Chewing Gum Tester

ERWEKA DRT ................................................................................................................. 93

Automatic Blasting station............................................................................................... 95

Semi automatic cleaning station ................................................................................. 95
Detergents Tester
ERWEKA RT 700 ............................................................................................................. 96

Disintegration Testers
ERWEKA ZT 120 series ...............................................................................97
1 test station, type ZT 121 ................................................................................................ 97
2 test stations, type ZT 122 .............................................................................................. 97
3 test stations, type ZT 123 .............................................................................................. 97
4 test stations, type ZT 124 .............................................................................................. 97
ERWEKA ZT 220 series ...............................................................................98
1 test station, type ZT 221 ................................................................................................ 98
2 test stations, type ZT 222 .............................................................................................. 98
3 test stations, type ZT 223 .............................................................................................. 98
4 test stations, type ZT 224 .............................................................................................. 98
ERWEKA ZT 320 series ...............................................................................99
1 test station, type ZT 321 ................................................................................................ 99
2 test stations, type ZT 322 .............................................................................................. 99
3 test stations, type ZT 323 .............................................................................................. 99
4 test stations, type ZT 324 .............................................................................................. 99

4
 ERWEKA ZTm 320 series ..........................................................................101
1 test station, type ZT 321 .............................................................................................. 101
2 test stations, type ZT 322 ............................................................................................ 101
3 test stations, type ZT 323 ............................................................................................ 101
4 test stations, type ZT 324 ............................................................................................ 101
Qualification ...............................................................................................102
Qualification documents for Disintegration Testers
Qualification tools for Disintegration Testers
ERWEKA PQ tablets

Tablet Friability-/ Abrasion Testers

ERWEKA TA Series ...................................................................................103
TA 120 (for one drum, left) ............................................................................................. 103
TA 220 (for two drums, left and right) ............................................................................. 103
TA 420 (for two double drums, left and right) ................................................................ 103
ERWEKA TAR Series.................................................................................103
TAR 120 (for one drum, left)........................................................................................... 103
TAR 220 (for two drums, left and right) .......................................................................... 103
TAR 420 (for two drums, left and right) .......................................................................... 103
ERWEKA TDR 100 .....................................................................................104
Balances for connection to TDR..................................................................................... 104
Options for TDR ............................................................................................................. 104
Friability- and Abrasion Drums ................................................................105
Qualification ...............................................................................................105
Qualification tools for tablet Friability-/ -Abrasion testers ............................................... 105
Spare parts for Qualification tools and ERWEKA PQ tablets ........................................ 105
ERWEKA GTA 120 Bottle Friability Tester ..............................................107

Tablet Hardness Testers

ERWEKA TBH 125 ......................................................................................................... 108
ERWEKA TBH 225 ......................................................................................................... 109
ERWEKA TBH 225 D ..................................................................................................... 109
ERWEKA TBH 225 TD ................................................................................................... 110
ERWEKA TBH 225 WTD ............................................................................................... 110
ERWEKA TBH 225 Industrial Version ......................................................................... 113
ERWEKA TBH 325 ......................................................................................................... 114
ERWEKA TBH 325 D ..................................................................................................... 114
ERWEKA TBH 325 TD ................................................................................................... 115
ERWEKA TBH 325 WTD ............................................................................................... 115
ERWEKA TBH 425 ......................................................................................................... 118
ERWEKA TBH 425 D ..................................................................................................... 118
ERWEKA TBH 425 TD ................................................................................................... 119
ERWEKA TBH 425 WTD ............................................................................................... 119
ERWEKA TBH 525 ......................................................................................................... 121
MultiCheck 5.1 ................................................................................................................ 123

5
 Qualification ...............................................................................................126
Qualification documents for Tablet Hardness Testers ................................................... 126
Qualification tools for Tablet Hardness Testers ............................................................. 126
Calibration/Qualification tools for diameter and thickness measuring station ................ 126
Calibration/Qualification tools for weight measuring station .......................................... 126
Hardness Test Station, Static Calibration Tools............................................................. 127
Hardness Test Station, Dynamic Calibration Tool ......................................................... 127
ERWEKA PQ Tablets ..................................................................................................... 127

Modular Check Weighing Systems

ERWEKA CWS ...........................................................................................128
Options for ERWEKA CWS ............................................................................................ 128
Software ......................................................................................................................... 128
Qualification ...............................................................................................129
Qualification document for Check Weighing System, type CWS ................................... 129
Calibration/Qualification tools for weight measuring station .......................................... 129
ERWEKA PQ tablets ...................................................................................................... 129

Powder & Granulate Testers - Bulk Density

ERWEKA GTL.............................................................................................130
Options ........................................................................................................................... 130
ERWEKA GT ...............................................................................................130
Options ........................................................................................................................... 130
ERWEKA GTB ............................................................................................131
Options ........................................................................................................................... 131
ERWEKA SMG............................................................................................131
Qualification ...............................................................................................131
Qualification documents for Granulate-Flow Testers ..................................................... 131
Qualification tools for GT/B series .................................................................................. 131

Powder & Granulate Testers - Tapped Density

ERWEKA SVM 121 and 221 .......................................................................132
SVM 121 (one test station) ............................................................................................. 132
SVM 221 (two test stations) ........................................................................................... 132
ERWEKA SVM 122 and 222 .......................................................................132
SVM 122 (one test station) ............................................................................................. 132
ERWEKA SVM 223 .....................................................................................133
Glassware for SVM series .............................................................................................. 133
Qualification ...............................................................................................133
Qualification documents Tapped Density Testers.......................................................... 133
Qualification tools for SVM series .................................................................................. 133

Suppository Testers
ERWEKA Suppository Hardness Tester, type SBT 2 .................................................... 134
ERWEKA Suppository Melting Point Tester, type SSP ................................................. 134
ERWEKA Circulation Heater, EST 2 .............................................................................. 134
ERWEKA Suppository Penetration Tester, type PM 30 ................................................. 134
ERWEKA Suppository Disintegration Tester, type ST 32 .............................................. 135
ERWEKA Suppository Disintegration Tester, type ST 35 .............................................. 136

6
All-Purpose-Equipment
1. Motors .....................................................................................................137
1.1. AR 403 .................................................................................................................... 137
1.2. AR 403-S ................................................................................................................. 137
1.3. AMD......................................................................................................................... 137
Options for AR 403/-S and AMD .................................................................................... 137

2. Attachments ........................................................................... 138

Universal Gear, UG ........................................................................................................ 138
Three-Roller-Mill, SM/SMS............................................................................................. 138
Homogeniser, HO/HHO .................................................................................................. 138
Planetary Stirrer, PRS .................................................................................................... 138
Laboratory Kneader, LK5 ............................................................................................... 139
Suppository and Lipstick Moulding Machine, SG 4/W ................................................... 139
Filling and Dosing Machine for Liquids, FDF ................................................................ 139
Filling and Dosing Machine for Ointments and Crmes, FDS ...................................... 139
Ball Mills, KM .................................................................................................................. 140
Double Cone Mixer, DKM ............................................................................................... 140
Drum Hoop Mixer, RM .................................................................................................... 140
Y-Blender, YB 5 .............................................................................................................. 140
Vibration Sieve Shaker, VT ............................................................................................ 141
Sieve Sets ...................................................................................................................... 141
Coating Pan DKE/DKS ................................................................................................... 141
Polishing Drum ............................................................................................................... 142
Wet Granulator, FGS ...................................................................................................... 142
Dry Granulator, St. Steel, TG 2000 ................................................................................ 142
Pelletiser, GTE ............................................................................................................... 142
Cube Mixers, KB ............................................................................................................ 143
High Speed Mixer, SW 1/S............................................................................................. 143
Conical Mill, CM 60/UD .................................................................................................. 143

Tablet Presses
Single Punch Tablet Press, EP-1 ..............................................................144
Options ............................................................................................................................ 144
16-Station Rotary Tablet Press, ERWEKA TR-B 16 ................................145
Options for TR-B 16 ...................................................................................................... 145
8-Station Rotary Tablet Press, ERWEKA TR-D 8 ....................................146
Options for TR-D 8 ........................................................................................................ 146
Instrumentation of TR-B 16 / TR-D 8 ........................................................147
Roller Compactor RCC 100 x 20 Pharma .................................................148
Fluid Bed system FB 05 ............................................................................149

Universal Automated Documentation for all kind of Rotary Tablet Presses

Diverter TabSelect and documentation software AutoDoc ............................................ 150

Blister Density Checker

ERWEKA Vacuum Density Tester, type VDT ................................................................ 151

7
Inhaler Testers
Metered Dose Inhalers (MDI's) .................................................................152
ERWEKA Type Dosage United Sampling App. DUSA-MDI .......................................... 152
Andersen Type Cascade Impactor App. 1 .................................................................... 152
Dry Powder Inhalers (DPI's) .....................................................................153
ERWEKA Type Dosage United Sampling App., Type DUSA-DPI ................................. 153
Andersen Type Cascade Impactor App. 3 ..................................................................... 153
Multi-Stage Liquid Impinger (MSLI) .........................................................154
ASTRA Draco Multi-Stage Liquid Impinger (MSLI) ........................................................ 154
Single Stage Glass Impinger Glaxo (EP App. A) ........................................................... 154
Single Stage Metal Impactor Fisions .............................................................................. 154
Inhaler Accessories ..................................................................................155
ERWEKA vacuum pump type VP 1000 ......................................................................... 155
Testing unit for dry powder inhalations, type TP-DG-DPI 1000 ..................................... 155
Digital Flow Meter type DFM stand alone unit ............................................................... 156
ERWEKA vacuum pump type HVP ................................................................................ 156
Options Inhaler..........................................................................................157
Leak test kit .................................................................................................................... 157
Mouth piece adaptors ..................................................................................................... 157
Carrying cases ............................................................................................................... 157
IVIS Stage Mensuration ................................................................................................. 157

Services
Installation ...................................................................................................................... 158
Qualification/Qualification ............................................................................................... 158
Calibration ...................................................................................................................... 159
Maintenance ................................................................................................................... 159
Leasing ........................................................................................................................... 159
Used Equipment ............................................................................................................. 159

General Information about Dissolution Testing

USP Methods and major organizations .......................................................................... 160

All technical data is subject to change.

ERWEKA

8
Examples for ordering
1. ERWEKA Friability-/Abrasion Tester with two test stations (230V/50Hz), Friability Drum left
with certificate, Abrasion Drum right without certificate, USB interface and Qualification docu-
ment (IQ/OQ/PQ)

12-325-0001 ERWEKA Friability-/Abrasion Tester, Type TAR 220 (230V/50Hz)

11-3x5-2xxx Friability Drum, left, certified
11-3x5-x3xx Abrasion Drum, right
12-325-2301 TAR 220 (230V/50Hz) with Friability Drum left (certified) and
Abrasion Drum right
82-249-0000 USB interface
86-315-9999 Qualification document (IQ/OQ/PQ) for ERWEKA TAR Series

2. ERWEKA Dissolution Tester, Type DT 626 Low Head, with 6 test stations (1.000 ml),
230V/60Hz, with automatic USP sampling station (Teflon tubing 3.0 mm o.d.)

14-060-6001 ERWEKA DT 626 LH, 230V/60Hz with glass vessels and paddles
14-06x-xx1x USB printer interface (PCL 3/5) for hard-copy documentation of test-
run parameters, calibration routines etc. Upgraded electronics (real
time watch) and instrument menu (printer settings, time/date settings
etc.)
14-060-6011 ERWEKA DT 626 (230V/60Hz) with automatic USP sampling sta-
tion and centering tools made of [Link]

3. ERWEKA Disintegration Tester ZT 320 Series with 1 Test Station, 115V/60Hz, USB interface,
2 spare part kits for USP basket rack assembly, Qualification document (IQ/OQ/PQ) and
Qualification tool kit in certified version.

12-231-0003 ERWEKA ZT 321, 115V/60Hz

12-23x-xx1x USB interface
12-231-0013 ERWEKA ZT 321, 115V/60Hz with USB interface
92-240-0001 (2) 2 Spare part kits for USP basket rack assembly
65-230-9999 Qualification document (IQ/OQ/PQ) for ZT 320 Series
67-240-0000 Qualification tool kit, certified, for ZT 120/220/320 Series

9
Dissolution Tester (USP apparatus 1, 2, 5 and 6)
ERWEKA DT 820
6, 7 and 8 stirrer type

ERWEKA DT 820 has been designed with in- Video monitoring and recording
creased memory capacity to control complete Pre-heat function
Dissolution Offline Systems for advanced Optional monitoring of the media tempera-
stand-alone operation. tures by up to 8 electronic PT 100
DT 820 allows storage of up to 100 product Calibration menu for quick calibration of
test-run parameters which can be interchanged the 1 or 9 temperature sensors
between various DT 820s by USB memory Shaft wobble less than 0.2 mm at delivery
stick. Quick exchange system for the stirring
The unit, as far as possible is made from car- methods by magnets (MagniShaft)
bon fibre to reduce any risk of corrosion. Corrosion-free plate for holding the
DT 820 can be used in conventional High-Head vessels
mode and low-evaporation Low-Head mode. Programme menu for storage of the
14-080-6001-4 monographs of up to 100 products
Automatic self-check of the temperature in
the bath/vessels before test start
Optional Online OQ-Check for rpm Alpha-numeric touch sensitive keypad
Integrated System-Suitability Test menu (IBM configuration) with illuminated full-
with documentation print-out graphic 6 display
Hours of operation counter RS 232 and RS 485 serial interfaces for
Logbook function with three user levels for external control
the last 600 users (On-/Off-time, name and USB printer interface for documentation of
OQ Traffic Light status) the test run parameters (time, date, rpm,
Automatic height adjustment temperatures etc.) by a standard printer
Automatic vessel centering (PCL 3 language)
Standard Tablet Drop Magazine for 8 Optional USP Sampling Station with auto-
samples. Optional automatic tablet drop matic height adjustment of the USP sam-
with control of temperature tolerance pling points
(USP) before drop Optional upgraded programme menu (i-
Evaporation less than 0.3% in Low Head version) for the control of a complete Off-
mode and less than 0.7% in High Head line Dissolution System by the
mode (24h/37.0C) Dissolution Tester itself
pH Change routines, menu guided Optional video monitoring of six test posi-
Optic and acoustic reminder for manual tions
sampling (count-down)
Manual Lifter with hydraulic support
One-piece leak-free moulded, illuminated
water bath with outlet cock (optional)
PT 100 external temperature sensor for
water bath- or media temperature display
External heating system with control by the
keypad and LC display of the DT 820; ac-
curacy 0.2C
Temperature sensors

10
ERWEKA DT 826 Shaft Systems
6 test stations, 2 reference positions MagniShaft or UniShaft
For 6 stirring elements and DT 820 is available with
holding 8x1000 ml vessel two different Shaft sys-
tems:
230V/50-60Hz 14-080-6001 1.) MagniShaft for magnet-
115V/60Hz 14-080-6003 ic connection between
127V/60Hz 14-080-6004 stirring element and
drive or
ERWEKA DT 827 2.) UniShaft for screw
7 test stations, 1 reference position connection.

For 7 stirring elements and Both systems comprise of an upper Shaft (in-
holding 8x1000 ml vessel; side the drive head) and a lower shaft to which
Additional price the paddle or basket holder, transdermal cylin-
der (only UniShaft) or Intrinsic Dissolution Kit
(only UniShaft) is connected.
230V/50-60Hz 14-080-7001
115V/60Hz 14-080-7003 While MagniShaft is only available for Low-
127V/60Hz 14-080-7004 Head use UniShaft system can be ordered for
both, Low-Head and High-Head use.
ERWEKA DT 828 MagniShaft is made for simultaneous test start
8 test stations while at UniShaft system the test start can be
performed simultaneous or staggered.
For 8 stirring elements and
holding 8x1000 ml vessel; While the upper shaft is generally made from
Additional price stainless steel the lower parts is mould from
Teflon with an integrated stainless steel core.
230V/50-60Hz 14-080-8001 On special request stainless steel stirring ele-
115V/60Hz 14-080-8003 ments are available.
127V/60Hz 14-080-8004
All parts are numbered and optionally come
with a certificate of USP/EP compliance.

2000 ml Version
For holding ERWEKA USP compliant 2000 ml
vessels; water bath made from acrylic glass
instead mould PET water bath. For UniShaft
only (High-Head and/or Low-Head configura-
tion). Additional price 14-1xx-xxxx

11
Options Sample Withdraw Systems
Cyrillic keypad and Russian operation Prepared for upgrade to Sampling Station
menu; instead Latin keypad and English / (without automated sampling station)
German operation menu 14-x8x-x1xx
14-080-6005
Additional Sampling Station with stainless
Automated, simultaneous, tablet drop steel sampling- and replacement tubes,
magazine; samples are automatically Teflon tubing, without motor, for use with
dropped when temperature within the USP sampling station drive. 84-070-0115
specified range. Staggered tablet drop is
possible (manually) 84-070-0010 USP/EP/JP
compliant Sam-
Online OQ-Check for rpm by a second pling Station with
high precision sensor. automatic height
Warning screen when adjustment of the 16 USP sampling
rpm is out of tolerance heights. Teflon Tubing 1.6 mm o.d.
(connected to OQ Traf- 14-x8x-x2xx
fic Light)
89-080-0002 USP/EP/JP
compliant Sam-
pling Station with
automatic height
adjustment of the 16 USP sampling
heights. Teflon Tubing 3.0 mm o.d.
14-x8x-x4xx
Illumination of the water bath by LEDs
84-090-0112 with 8 additional
electronic PT 100
Print LAN converter for the data transfer to temperature sen-
network printers 84-090-0111 sors for display
and documenta-
Water Stabiliser with colour indicator, tion of the
1 bottle media temperatures in all vessels, incl.
80-080-0002 automatic USP sampling station, Teflon
Tubing 1.6 mm o.d. 14-x8x-x6xx

with 8 additional
electronic PT 100
temperature sen-
sors for display
and documenta-
tion of the
media temperatures in all vessels, incl.
automatic USP Sampling Station, Teflon
Funnel Tubing 3.0 mm o.d. 14-x8x-x9xx

With extension (plastics) for entering gran- Additional price for

ules/powders and/or adding buffer solution Double Filtration station
through the sampling openings (Low-Head for holding membrane
mode) 84-060-1500 filters
84-070-0955

12
 Titanium sampling- and replacement Vessel Centring Rings
probes (corrosion-free) instead of stainless
steel probes, at additional cost Vessel-Centring- and Down-Holding-ring;
80-090-0200 for all kind of 1000 ml ERWEKA Vessels
84-060-3000
Cleaning reservoir (acrylic glass) with 3
separate compartments for cleaning of DT
820/720 sampling stations. The 3 com-
partments eliminate any possibility of con- Vessel Support Plate
tamination 80-089-0000
Vessel Support Plate (plastics) with bayo-
net openings for Vessel-Centring-Ring for
ERWEKA Vessels 84-060-1000

Vessel Covers
V-Shaped vessel
Electronic Calibration Kit for PT 100 tem- covers made of
perature sensor/s. Teflon (instead
This kit allows fast calibration of the exter- plastics) for even
nal electronic PT 100 temperature sensor lower evaporation.
as well as the 8 additional temperature 84-060-0001
sensors without the use of water.
This not only eliminates the need of pre- Low-Evaporation Vessel-Cover (1000 ml
heated water, it also saves up to 95% of ERWEKA Vessel) for High-Head use; addi-
the time needed 10-092-0001 tional standard V-shaped Vessel-Cover
84-000-0310

Spare Part Kits

Paddles, Baskets, Discs for Paddle over
Spare part kit for DT 820 comprising of 1 Disc, Rotating Cylinder and Glassware
paddle with shaft, 1 vessel 1000ml, 1 PT please see Accessories.
100 temperature sensor, 1 belt, 2 fuses, 1
stirrer (please specify the type of Shaft
System) 94-080-0001

Spare part kit for DT 820 with automatic

USP Sampling Station comprising of spare
part kit 94-080-0001 and 1 belt, 2 [Link]
sampling probes, 2 [Link] return probes
and 8 tube connectors 94-080-0002

Spare part kit for DT 820 with automatic

USP Sampling Station and 8 temperature
sensor option, incl. 94-080-0002
94-080-0003

13
ERWEKA DT 720
6, 7 and 8 stirrer type

ERWEKA DT 720 has been designed with the Automatic vessel centring
user in mind: instead of an extensive operation One-piece leak-free moulded, illuminated
menu structure and multi-functional keys the DT (optional) water bath with outlet cock
720 comes with individual displays for each Corrosion-free plate for holding the vessels
test-run parameter (time, rpm, temperature). Evaporation less than 0.3% in Low Head
UP/DOWN buttons for fast and easy test-run mode and less than 0.7% in High Head
parameter setting are placed. For better obser- mode (24h/37.0C)
vation of the sample dissolving process the External heating system with control by the
one-piece moulded water bath (with standard keypad and LE display of the DT 720; ac-
water outlet cock) is illuminated (optional). curacy 0.2C
The manual lifter column, with hydraulic support Standard Tablet Drop Magazine for 8
for effortless operation, allows raising and low- samples. Optional automatic tablet drop
ering of the drive head in just a few seconds. with control of temperature tolerance
Tablets/Pellets etc. are inserted through the (USP) before drop
sampling openings in the drive head via the Internal PT 100 temperature sensor for
standard tablet delivery system. Samples for water bath temperature display
analysis are withdrawn through special, mem- Optional external PT 100 temperature sen-
brane sealed sampling openings inside the sor for water bath- or media temperature
drive head. Evaporation less than 0.3% in Low display
Head mode and less than 0.7% in High Head Optional monitoring of the media tempera-
mode (24h/37.0C). tures by electronic PT 100 temperature
The extensive use of carbon fibre allowed to sensors
eliminate metal and therefore reduces the risk Calibration menu for quick calibration of
of corrosion to a minimum. the 1 or 9 temperature sensors
The actual test-run parameters can be docu- Shaft wobble less than 0.2 mm at delivery
mented via an USB printer (optional). Height adjustable feed for levelling
Automatic self-check of the temperature in
Easy and comfortable operations: the bath/vessels before test start
UP/DOWN and START/STOP buttons for Hours of operation counter
test parameter setting as well as individual RS 232 serial interfaces for external con-
big and bright LE displays for display trol
Manual Lifter with hydraulic support Optional USB printer interface for docu-
Low-Head operations (MagniShaft or Un- mentation of the test run parameters (time,
iShaft) date, rpm, temperatures etc.) by a stan-
Low-Head- and High-Head operations dard printer (PCL 3 language)
(UniShaft only) Optional USP Sampling Station with auto-
Quick exchange system for the stirring matic height adjustment of the USP sam-
methods by magnets (MagniShaft) pling points to create a Dissolution Sys-
Automatic height adjustment of the stirring tem
elements Optional video monitoring of six test posi-
Video monitoring and recording tions

14
ERWEKA DT 726 Shaft Systems
6 test stations, 2 reference positions MagniShaft or UniShaft
For 6 stirring elements DT 720R is available with
and holding 8x 1000 ml two different Shaft sys-
vessel tems:
230V/50-60Hz 14-070-6001 1.) MagniShaft for mag-
115V/60Hz 14-070-6003 netic connection be-
127V/60Hz 14-070-6004 tween stirring element
and drive or
ERWEKA DT 727 2.) UniShaft for screw
7 test stations, 1 reference position connection.

For 7 stirring elements Both systems comprise of

and holding 8x 1000 ml an upper Shaft (inside the drive head) and a
vessel; Additional price lower Shaft to which the Paddle or Basket hold-
er, Transdermal Cylinder (only UniShaft) or
230V/50-60Hz 14-070-7001 Intrinsic Dissolution Kit (only UniShaft) is con-
115V/60Hz 14-070-7003 nected.
127V/60Hz 14-070-7004
While MagniShaft is only available for Low-
Head use UniShaft system can be ordered for
ERWEKA DT 728 both, Low-Head- and High-Head use.
8 test stations
MagniShaft is made for simultaneous test start
For 8 stirring elements while at UniShaft system the test start can be
and holding 8x 1000 ml performed simultaneous or staggered.
vessel; Additional price
230V/50-60Hz 14-070-8001 While the upper Shaft is generally made from
115V/60Hz 14-070-8003 stainless steel the lower parts is mould from
127V/60Hz 14-070-8004 Teflon with an integrated stainless steel core.
On special request stainless steel stirring ele-
ments are available.

2000 ml Version All parts are numbered and optionally come

For holding ERWEKA USP compliant 2000 ml with a certificate of USP/EP compliance.
vessels; water bath made from acrylic glass
instead mould PET water bath. For UniShaft
only (High-Head and/or Low-Head configura-
tion). Additional price 14-1xx-xxxx

15
Options Sample Withdraw Systems
Automated, simultaneous, tablet drop Prepared for upgrade to Sampling Station
magazine; Samples are automatically (without automated sampling station)
dropped when temperature within the USP 14-x8x-x1xx
specified range. Staggered tablet drop is
possible (manually) 84-070-0010 Additional Sampling Station with stainless
steel sampling- and replacement tubes,
External electronic temperature sensor PT Teflon tubing, without motor, for use with
100 for display of water bath - or media sampling station drive. 84-070-0115
temperature. Extended instrument menu for
one-point calibration routine as well as cali- USP/EP/JP
bration hard-copy documentation (when compliant Sam-
equipped with USB printer interface) pling Station with
84-070-0100 automatic height
adjustment of the 16 USP sampling
USB printer interface (PCL 3) for hard- heights. Teflon Tubing 1.6 mm o.d.
copy documentation of test-run parame- 14-x8x-x2xx
ters, calibration routines etc. Upgraded
electronics (real time watch) and instru- USP/EP/JP
ment menu (printer settings, time/date set- compliant Sam-
tings etc.). 14-07x-xx1x pling Station with
automatic
Illumination of the water bath by LEDs height adjustment of the 16 USP sampling
84-090-0112 heights. Teflon Tubing 3.0 mm o.d.
14-x8x-x4xx
Water Stabiliser with col-
our indicator, 1 bottle with 8 additional
80-080-0002 electronic PT 100
temperature sen-
sors for display
and documen-
tation of the media temperatures in all ves-
sels, incl. automatic USP Sampling Sta-
tion, Teflon Tubing 1.6 mm o.d.
14-x8x-x6xx

Funnel with 8 additional

electronic PT 100
with extension (plastics) for entering gran- temperature sen-
ules/powders and/or adding buffer solution sors for display
through the sampling openings (Low-Head and documen-
mode) 84-060-1500 tation of the media temperatures in all ves-
sels, incl. automatic USP Sampling Sta-
tion, Teflon Tubing 3.0 mm o.d.
14-x8x-x9xx

Additional price for

Double Filtration station
for holding membrane
filters 84-070-0955

16
 Titanium sampling- and replacement Vessel Centring Rings
probes (corrosion-free) instead of stainless
steel probes, at additional cost Vessel-Centring-Ring and Down-Holding-
80-090-0200 Ring; for all kind of 1000 ml ERWEKA
Vessels 84-060-3000
Cleaning reservoir (acrylic glass) with 3
separate compartments for cleaning of DT
720/820 sampling stations. The 3 com- Vessel Support Plate
partments eliminate any possibility of con-
tamination 80-089-0000 Vessel Support Plate (plastics) with bayo-
net openings for Vessel-Centring-Rings for
ERWEKA Vessels 84-060-1000

Vessel Covers
V-Shaped vessel
Covers made of Tef-
lon (instead Delrin) for
even lower evapora-
tion
Electronic Calibration Kit for PT 100 tem- 94-060-0001
perature sensor/s.
This kit allows fast calibration of the exter- Low-Evaporation
nal electronic PT 100 temperature sensor Vessel-Cover (1000 ml
as well as the 8 additional temperature ERWEKA Vessel) for
sensors without the use of water. High-Head use; addi-
This not only eliminates the need of pre- tional To standard V-
heated water, it also saves up to 95% of shaped Vessel-Cover
the time needed 10-092-0001
84-000-0310
Spare Part Kits
Spare part kit for DT 720 comprising of 1
paddle with shaft, 1 centring ring, 1 vessel Paddles, Baskets, Discs for Paddle over
1000ml, 1 belt, 2 fuses, 1 stirrer (please Disc, Rotating Cylinder and Glassware
specify the type of Shaft System) please see Accessories.
94-070-0001

Spare part kit for DT 720 with automatic

USP Sampling Station comprising of spare
part kit 94-070-0001, 2 [Link] sampling
probes, 2 [Link] return probes and 8 tube
connectors 94-070-0002

Spare part kit for DT 720 with automatic

USP Sampling Station and 8 temperature
sensor option, incl. 94-070-0002
94-070-0003

17
ERWEKA DT 720R
6 and 7 stirrer type

ERWEKA DT 720R is based on the DT 720

user interface (keypad/displays), but fitted with
7 vessels (6 or 7 stirrers) in one row for easy
access, e.g. for manual sample withdraw. The
unit is available with video monitoring and re-
cording for 6 test stations as well as with vessel
capacities of 250 ml, 1000 ml or 2000 ml (spe-
cial request).

Easy and comfortable operations: Optional monitoring of the media tempera-

UP/DOWN and START/STOP buttons for tures by electronic PT 100 temperature
test parameter setting as well as individual sensors
big and bright LE displays for display Calibration menu for quick calibration of
Manual Lifter with hydraulic support the 1 or 9 temperature sensors
Low-Head operations (MagniShaft) Shaft wobble less than 0.2 mm at delivery
Low-Head- and High-Head operations Height adjustable feed for levelling
(UniShaft) Automatic self-check of the temperature in
Quick exchange system for the stirring the bath/vessels before test start
methods by magnets (MagniShaft- or Un- Hours of operation counter
iShaft) RS 232 serial interfaces for external con-
Automatic height adjustment of the stirring trol
elements Optional USB printer interface for docu-
Automatic vessel centering mentation of the test run parameters (time,
Acrylic glass water bath date, rpm, temperatures etc.) by a stan-
Corrosion-free plate for holding the vessels dard printer (PCL 3 language)
Evaporation less than 0.3% in Low Head Optional USP Sampling Station with auto-
mode and less than 0.7% in High Head matic height adjustment of the USP sam-
mode (24h/37.0C) pling points to create a Dissolution Sys-
External heating system with control by the tem
keypad and LE display of the DT 720R; Optional video monitoring of six test posi-
accuracy 0.2C tions
Standard Tablet Drop Magazine for 8
samples. Optional automatic tablet drop
with control of temperature tolerance
(USP) before drop
Internal PT 100 temperature sensor for
water bath temperature display
Optional external PT 100 temperature sen-
sor for water bath- or media temperature
display

18
ERWEKA DT 726R Shaft Systems
6 test stations, 1 reference positions MagniShaft or UniShaft
For 6 stirring elements and holding
7x 1000 ml vessel DT 720R is available with
two different Shaft sys-
230V/50-60Hz 14-050-6001 tems:
115V/60Hz 14-050-6003
127V/60Hz 14-050-6004 1.) MagniShaft for mag-
netic connection be-
tween stirring element
ERWEKA DT 727R and drive or
7 test stations, without reference po- 2.) UniShaft for screw
sition connection.
For 7 stirring elements and holding
7x 1000 ml vessel; Additional price Both systems comprise of
an upper Shaft (inside the drive head) and a
230V/50-60Hz 14-050-7001 lower Shaft to which the Paddle or Basket hold-
115V/60Hz 14-050-7003 er, Transdermal Cylinder (only UniShaft) or
127V/60Hz 14-050-7004 Intrinsic Dissolution Kit (only UniShaft) is con-
nected.

While MagniShaft is only available for Low-

Head use UniShaft system can be ordered for
both, Low-Head- and High-Head use.

MagniShaft is made for simultaneous test start

while at UniShaft system the test start can be
performed simultaneous or staggered.

While the upper Shaft is generally made from

stainless steel the lower parts is mould from
Teflon with an integrated stainless steel core.
On special request stainless steel stirring ele-
ments are available.

All parts are numbered and optionally come

with a certificate of USP/EP compliance.

19
Options Spare Part Kits
Automated, simultaneous, tablet drop Spare part kit for DT 720R comprising of 1
magazine for DT 720 R; Samples are paddle with shaft, 1 PT100 temperature
automatically dropped when temperature sensor, 1 centring ring, 1 vessel 1000ml, 1
within the USP specified range. Staggered belt, 2 fuses, 1 stirrer (please specify the
tablet drop is possible (manually) type of Shaft System)
84-070-0010 94-070-0001

External electronic temperature sensor PT Spare part kit for DT 720R with automatic
100 for display of water bath - or media USP Sampling Station comprising of spare
temperature. Extended instrument menu for part kit 94-070-0001, 2 [Link] sampling
one-point calibration routine as well as cali- probes, 2 [Link] return probes and 8 tube
bration hard-copy documentation (when connectors 94-070-0002
equipped with USB printer interface)
84-070-0100 Spare part kit for DT 720 R with automatic
USP Sampling Station and 8 temperature
USB printer interface (PCL 3) for hard- sensor option, incl. 94-070-0002
copy documentation of test-run parame- 94-070-0003
ters, calibration routines etc. Upgraded
electronics (real time watch) and instru-
ment menu (printer settings, time/date set- Vessel Centring Rings
tings etc.) 14-07x-xx1x
Vessel-Centring- and Down-Holding-
Water Stabiliser with col- Ring; for all kind of 1000 ml ERWEKA
our indicator, 1 bottle Vessels 84-060-3000
80-080-0002

Vessel Support Plate

Vessel Support Plate (plastics) with bayo-
net openings for Vessel-Centring-Rings for
ERWEKA Vessels 84-060-1000

Funnel Vessel Covers

with extension (plastics) for entering gran- V-Shaped vessel
ules/powders and/or adding buffer solution Covers made of
through the sampling openings (Low-Head Teflon (instead Del-
mode) 84-060-1500 rin) for even lower
evaporation
94-060-0001

Low-Evaporation
Vessel-Cover (1000
ml ERWEKA Vessel)
for High-Head use;
additional to stan-
dard V-shaped Ves-
sel-Cover
84-000-0310

Paddles, Baskets, Discs for Paddle over

Disc, Rotating Cylinder and Glassware
please see Accessories.

20
ERWEKA DT 720-4000
6 or 7 stirrer type

ERWEKA DT 720-4000 High-Head is based on

the DT 720 user interface (keypad / displays),
ERWEKA DT 726 HH - 4000
but fitted with 7 vessels (6 or 7 stirrers) of 4000 6 test stations, 1 reference position;
ml capacity. for UniShaft only
Easy and comfortable operations: For 6 stirring elements and holding 7x4000 ml
UP/DOWN and START/STOP buttons for vessel
test parameter setting as well as individual
big and bright LE displays for display 230V/50-60Hz 14-074-6001
Manual lifters with hydraulic support 115V/60Hz 14-074-6003
High-head operations (UniShaft) 127V/60Hz 14-074-6004
Quick exchange system for the stirring
methods by screw system
Automatic height adjustment of the stirring
ERWEKA DT 727 HH - 4000
elements 7 test stations; for UniShaft only
Vessel centring tools
Acrylic glass water bath For 7 stirring elements and holding 7x4000 ml
Corrosion-free plate for holding the vessels vessel; Additional price
External heating system with control by the
keypad and LE display of the DT 720R; 230V/50-60Hz 14-074-7001
accuracy 0.2C 115V/60Hz 14-074-7003
Internal PT 100 temperature sensor for 127V/60Hz 14-074-7004
water bath temperature display
Optional external PT 100 temperature sen- Shaft System
sor for water bath- or media temperature
display
UniShaft
Calibration menu for quick calibration of
The DT 720-4000, due to its High-Head opera-
the temperature sensor/s
tion, comes with the ERWEKA UniShaft sys-
Shaft wobble less than 0.2 mm at delivery
tem.
Height adjustable feed for levelling
Hours of operation counter
The system comprises of an upper Shaft (inside
Optional USB printer interface for docu-
the drive head) and a lower Shaft to which the
mentation of the test run parameters (time,
Paddle or Basket holder is connected.
date, rpm, temperatures etc.) by a stan-
dard printer (PCL 3 language)
All parts are numbered and optionally come
with a certificate of USP/EP compliance.

21
Options Vessel Support Plate
External electronic temperature sensor PT Vessel Support Plate (plastics) for Vessel-
100 for display of water bath - or media Centring-Rings for ERWEKA 4000 ml Ves-
temperature. Extended instrument menu sels 84-074-1000
for one-point calibration routine as well as
calibration hard-copy documentation (when
equipped with USB printer interface) Vessel Covers
84-070-0100
Low-Evaporation
USB printer interface (PCL 3) for hard- Vessel-Cover (4000
copy documentation of test-run parame- ml ERWEKA Ves-
ters, calibration routines etc. Upgraded sel) for High-Head
electronics (real time watch) and instru- use
ment menu (printer settings, time/date set- 84-000-0312
tings etc.) 14-07x-xx1x

Water Stabiliser with col- Paddles, Baskets, Discs for Paddle over
our indicator, 1 bottle Disc, Rotating Cylinder and Glassware
80-080-0002 please see Accessories.

Sample Withdraw System

Sampling and replacement probes (set of 7

probes, [Link]), fix in the media, manual
height adjustment. Teflon tubing 1.6 or 3.0
mm outside diameter 14-x74-x2xx

Sampling and replacement probes (set of 7

probes, Titanium), fix in the media, manual
height adjustment. Teflon tubing 1.6 or 3.0
mm outside diameter 14-x74-x4xx

Spare Part Kits

Spare part kit for DT 720-4000 comprising
of 1 paddle with shaft, 1 centring ring, 1
vessel 4000ml, 1 belt, 2 fuses, 1 stirrer
(please specify the type of Shaft System)
94-074-0001

22
ERWEKA DT 1420
12, 13 and 14 stirrer type

ERWEKA DT 1420 is based on DT 720 user

interface (DT 1420i is based on DT 820 user
interface), but fitted with 14 Vessels arranged in
two rows (12, 13 or 14 stirrers).
The DT 1420 offers the possibility for one test
with 12/13/14 tablets or two tests with 6/7 tab-
lets. This enables the user to carry out stage 2
USP tests within one bath at equal test condi-
tions.

Easy and comfortable operations: Calibration menu for quick calibration of

UP/DOWN and START/STOP buttons for the temperature sensors
test parameter setting as well as individual Shaft wobble less than 0.2 mm at delivery
big and bright LE displays for display Height adjustable feed for levelling
Manual Lifter with hydraulic support Automatic self-check of the temperature in
Low-Head operations (MagniShaft) the bath/vessels before test start
Low-Head- and High-Head operations Hours of operation counter
(UniShaft) USB interface for external control
Quick exchange system for the stirring Optional USB printer interface for docu-
methods by magnets (MagniShaft) mentation of the test run parameters (time,
Automatic height adjustment of the stirring date, rpm, temperatures etc.) by a stan-
elements dard printer (PCL 3 language)
Automatic vessel centering
Acrylic glass water bath
Corrosion-free plate for holding the vessels
Evaporation less than 0.3% in Low Head
mode and less than 0.7% in High Head
mode (24h/37.0C)
External heating system with control by the
keypad and LE display of the DT 1420; ac-
curacy 0.2C
Standard Tablet Drop Magazine for 14
samples. Optional automatic tablet drop
with control of temperature tolerance
(USP) before drop
Internal PT 100 temperature sensor for
water bath temperature display
Optional external PT 100 temperature sen-
sor for water bath- or media temperature
display

23
ERWEKA DT 1420 Shaft Systems
12 test stations, 2 reference posi- MagniShaft or UniShaft
tions DT 1420 is available with
For 12 stirring elements and holding 14x two different Shaft sys-
1000 ml vessel tems:

230V/50-60Hz 14-014-1201 1.) MagniShaft for mag-

115V/60Hz 14-014-1203 netic connection be-
127V/60Hz 14-014-1204 tween stirring element
and drive or
ERWEKA DT 1420 2.) UniShaft for screw
connection.
13 test stations, 1 reference position
For 13 stirring elements and holding 14x Both systems comprise of an upper Shaft (in-
1000 ml vessel; Additional price side the drive head) and a lower Shaft to which
the Paddle or Basket holder, Transdermal Cy-
230V/50-60Hz 14-014-1301 linder (only UniShaft) or Intrinsic Dissolution Kit
115V/60Hz 14-014-1303 (only UniShaft) is connected.
127V/60Hz 14-014-1304
While MagniShaft is only available for Low-
ERWEKA DT 1420 Head use UniShaft system can be ordered for
14 test stations both, Low-Head- and High-Head use.
For 14 stirring elements and holding 14x
1000 ml vessel; Additional price MagniShaft is made for simultaneous test start
while at UniShaft system the test start can be
230V/50-60Hz 14-014-1401 performed simultaneous or staggered. While
115V/60Hz 14-014-1403 the upper Shaft is generally made from stain-
127V/60Hz 14-014-1404 less steel the lower parts is mould from Teflon
with an integrated stainless steel core. On spe-
cial request stainless steel stirring elements are
available.

All parts are numbered and optionally come

with a certificate of USP/EP compliance.

24
Options Vessel Centring Rings
Automated Tablet Drop Magazine with Vessel-Centring-Ring and Down-Holding-
temperature control before drop. All sam- Ring; for all kind of 1000 ml ERWEKA
ples will be dropped simultaneously Vessels 84-060-3000
84-070-0100

External electronic temperature sensor PT Vessel Support Plate

100 for display of water bath - or media
temperature. Extended instrument menu Vessel Support Plate (plastics) with bayo-
for one-point calibration routine as well as net openings for Vessel-Centring-Rings for
calibration hard-copy documentation (when ERWEKA Vessels 84-060-1000
equipped with USB printer interface)
84-070-0010
Vessel Covers
USB printer interface (PCL 3) for hard-
copy documentation of test-run parame- V-Shaped vessel
ters, calibration routines etc. Upgraded Covers made of
electronics (real time watch) and instru- Teflon (instead Del-
ment menu (printer settings, time/date set- rin) for even lower
tings etc.) 14-07x-xx1x evaporation
94-060-0001
Water Stabiliser with colour
indicator, 1 bottle Low-Evaporation
80-080-0002 Vessel-Cover (1000
ml ERWEKA Vessel)
for High-Head use;
additional to stan-
dard V-shaped Ves-
sel-Cover
84-000-0310

Funnel
Paddles, Baskets, Discs for Paddle over
With extension (plastics) for entering gran- Disc, Rotating Cylinder and Glassware
ules/powders and/or adding buffer solution please see Accessories.
through the sampling openings (Low-Head
mode) 84-060-1500

Spare Part Kits

Spare part kit for DT 1420 comprising of 1
paddle with shaft, 1 centring ring, 1 vessel
1000ml, 1 belt, 2 fuses, 1 stirrer (please
specify the type of Shaft System)
94-070-0001

25
ERWEKA DT 620 High-Head
6 stirrer type, 1000 and 2000 ml ver-
sion

The basic ERWEKA stand-alone Dissolution Automatic self-check of the temperature in

Tester for all Laboratories and Universities the bath before test start
where high quality is required but the budget is Hours of operation counter
limited. The unit has the same quality than any Optional sample withdraw and replace-
other ERWEKA Dissolution Tester but it is ment tubes from stainless steel or Titanium
downgraded in respects of comfort and elec- to create a Dissolution System
tronics.
The user interface, water bath, heating system,
metal-free construction is similar to the DT 720
series but instead the DT 620 uses a fix drive
head in High-Head operation position and
ERWEKA DT 626
therefore only the UniShaft screw system 6 test stations
Shafts This bath allows easy access for manual
sampling due to the arrangement of the test
The DT 620 is designed for holding 6 vessels stations in U-shape. For holding 6x 1000 ml
and comes with 6 drives. Vessel

Easy and comfortable operations: 230V/50Hz 14-060-6001

UP/DOWN and START/STOP buttons for 230V/60Hz 14-060-6002
test parameter setting as well as individual 115V/60Hz 14-060-6003
big and bright LE displays for display 127V/60Hz 14-060-6004
Fix drive-head
High-Head operations (UniShaft) ERWEKA DT 626-2000
Quick exchange system for the stirring
methods by screw system
6 test stations
Automatic height adjustment of the stirring Similar to DT 626/ 1000 but for holding USP
elements round-bottomed glass vessels 1.000 ml and
Low Evaporation Vessel Cover less than 2.000 ml. Water bath made from acrylic
0.7% (24h/37.0C) glass.
Automatic vessel centring
One-piece leak-free moulded, illuminated 230V/50Hz 14-160-6001
(optional) water bath 230V/60Hz 14-160-6002
Corrosion-free plate for holding the vessels 115V/60Hz 14-160-6003
External heating system with control by the 127V/60Hz 14-160-6004
keypad and LE display of the DT 720; ac-
curacy 0.2C
Internal PT 100 temperature sensor for
water bath temperature display
Calibration menu for quick calibration of
the temperature sensor
Shaft wobble less than 0.2 mm at delivery
Height adjustable feed for levelling

26
Options Vessel Centring Rings
Drain valve on the bottom of the water bath Vessel-Centring- and Down-Holding-
84-060-xx1x Ring; for all kind of 1000 ml and 2000 ml
ERWEKA Vessels 84-060-3000
Illumination of the water bath by LEDs
14-090-6001 Vessel Support Plate
Sampling and Vessel Support Plate (plastics) with bayo-
replacement net openings for Vessel-Centring-Rings for
probes (set of 6 ERWEKA 1000 and 2000 ml Vessels
probes, [Link]), 84-060-1000
fix in the media,
manual height ad-
justment. Teflon Vessel Covers
tubing 1.6 or 3.0
mm outside diame- Low-Evaporation
ter (High-Head Vessel-Cover (1000
version 1000 ml ml and 2000 ml
only) ERWEKA Vessel)
14-06x-x6xx 84-000-0310

Sampling and replacement probes (set of 6

probes, [Link]), fix in the media, manual Paddles, Baskets, Discs for Paddle over
height adjustment. Teflon tubing 1.6 or 3.0 Disc, Rotating Cylinder and Glassware
mm outside diameter (High-Head version please see Accessories.
2000 ml only) 14-16x-x6xx

Water Stabiliser with

colour indicator, 1 bottle
80-080-0002

Spare Part Kit

Spare part kit comprising of 1 shaft, 1 ves-
sel, 1 belt, 2 fuses, 1 stirrer 1000 ml ver-
sion. 94-060-0001

Spare part kit comprising of 1 shaft, 1 ves-

sel, 1 belt, 2 fuses, 1 stirrer 2000 ml ver-
sion. 94-160-0001

27
Components, Pumps
1. Sample Transfer Pump
1.1. Transfer Pump IPC 8 1.2. Transfer Pump IPC 16
(8-channel Peristaltic Pump) (16-channel Peristaltic Pump)

With the standard ERWEKA 8-channel Peristal- With the standard ERWEKA 16-channel Peri-
tic Pump (IPC 8) the sample is taken from the staltic Pump (IPC 16) the sample is taken from
test vessel and transferred to the Autosampler the test vessel and transferred to the Autosam-
or flow-through cells of the spectrophotometer. pler or flow-through cells of the spectropho-
tometer.
Pump tubings are made of Verderprene (simi-
lar to Teflon) to prevent the absorption previ- Pump tubings are made of Verderprene (simi-
ously associated with peristaltic pumps and lar to Teflon) to prevent the absorption previ-
PVC tubing. ously associated with peristaltic pumps and
PVC tubing.
Via the serial RS 232 interface the pump is
controlled from the external PC. Via the serial RS 232 interface the pump is
controlled from the external PC.
8-channel Peristaltic Pump
RS 232 serial interface for external control 16-channel Peristaltic Pump
Touch sensitive keys and LC display RS 232 serial interface for external control
Verderprene tubing for elimination of ab- Touch sensitive keys and LC display
sorption of active ingredients by PVC tub- Verderprene tubing for elimination of ab-
ing sorption of active ingredients by PVC tub-
ing
11-202-5001 11-202-5002

Additional price set of verderprene tubing for Additional price set of verderprene tubing for
IPC 8 91-202-5001 IPC 16 91-202-5002

28
1.3. Transfer Pump, SP 725/10 1.4. Transfer Pump, SP 725/25
(7-channel Syringe Pump) (7-channel Syringe Pump)

The ERWEKA 7-channel Syringe Pump, Type The ERWEKA 7-channel Syringe Pump, Type
SP 725/10 with 10 ml syringes is the ideal me- SP 725/25 with 25 ml syringes is the ideal me-
dia transfer pump for the Offline Dissolution dia transfer pump for the Offline Dissolution
Systems with collection volumes of up to 5.0 ml. Systems, especially when collection of more
than 5.0 ml is required as well as for Dual
It offers very accurate volume flow, elimination Offline Systems and all kind of Online- and Off-
of absorption (glass/Teflon) and high flexibility /Online Systems.
due to an electric 4-way valve at the in-/outlet of
each syringe. This allows sampling, media re- It offers very accurate volume flow, elimination
placement and even dilution with one Dissolu- of absorption (glass/Teflon) and high flexibility
tion Tester using only one pump! due to an electric 4-way valve at the in-/outlet of
each syringe. This allows sampling, media re-
The SP 725/10 is equipped with a RS 232 inter- placement and even dilution with one Dissolu-
face for control by the upgraded programme tion Tester using only one pump!
menu (i-version) of ERWEKA DT 820 Dissolu-
tion Testers or [Link] software. The SP 725/25 is equipped with a RS 232 inter-
face for control by the upgraded programme
7-channel (optional 8-channel) Syringe menu (i-version) of ERWEKA DT 820 Dissolu-
Pump tion Testers.
Absorption free
Syringes 10 ml 7-channel (optional 8-channel) Syringe
Accuracy of volume 0.2 ml Pump
Sampling intervals from 2 minutes Absorption free
Automatic cleaning on completion/between Syringes 25 ml
the sampling intervals available Accuracy of volume 0.2 ml
Teflon tubing Sampling intervals from 2 minutes
Automatic cleaning on completion/between
SP 725/10, 7-channel version the sampling intervals available
11-200-7001 Teflon tubing

SP 825/10, 8-channel version SP 725/25, 7-channel version

11-200-8001 11-200-7011

SP 825/25, 8-channel version

11-200-8011

29
1.5. Transfer Pump PVP 720
(7-channel Piston Pump)

7-channel (optional 8-channel) high pressure,

valve free Teflon/Ceramics Piston Pump for all
Dissolutions Systems which require membrane
filtration below 1 m (dependant on the product
this pump allows filtration down to 0.22m)

High dosage accuracy ( 0.5 ml) and fast oper-

ation (sampling intervals from 2 minutes) in
combination with FRL 724/824 Fraction Collec-
tors.

PVP 720, 7-channel piston pump

11-312-1201

PVP 820, 8-channel piston pump

11-312-1211

30
2. Autosampler
2.1. Autosampler, FRL 720
Valve-free Autosampler for 7-, 8 or 14
channel operation

The 7-channel FRL 720 with x/y-driven sam- 10 ml or 25 ml glass tubes, a 1:1, 1:2, 1:5 or
pling arm was designed for silent operation and even 1:10 dilution can be obtained.
maximum corrosion resistance.
While in combination with a syringe pump the
To archive that the unit is mainly made from precise dosing of the collected sample is ar-
corrosion free materials such as alloy and plas- chived by the syringe, at the BUDGET and
tics and features a gentle and precise spindle BASE Offline Systems (peristaltic pump) the
drive. FRL 720 is responsible for the dosing accuracy
itself: the glass tubes are overfilled with media
The alloy rack-holder is made to carry various
then the stainless steel filling tubes move down
racks (glass tubes of 10 ml and 25 ml capacity
to the height level of the desired sample
as well as HPLC vials of 1.5 ml and 4.0 ml
amount and returns the sample above this level
maximum volume) to store max. 25 sampling
back to the vessel inside the dissolution tester.
intervals of 8 vessels or 12 sampling intervals of
15-207-1000
14 test stations (FRL 720-2 version to operate
with DT 1420). For temperature sensitive sam-
ples a cooled rack for HPLC vials is available.
Additional price 8-channel version, FRL 820
HPLC membrane piercing is realised by using a 15-208-1000
nd
2 spindle drive of the y-axis of the sampling
arm. The high-torque gear allows piercing of Additional price 14-channel version,
either split- or even none-split septum. FRL 720-2 15-214-1000

The medium replacement (if equipped) is per- Additional price media replacement (incl. two
formed by a 2-part container of which the re- 1-channel peristaltic pumps, 2-part acrylic
placement media section is constantly refilled glass container and replacement routine) 15-2xx-x1xx
by two 1-channel peristaltic pumps from an
external heated or unheated flask. This feature Additional price media replacement and
permits a) nearly unlimited amount of replace- automated dilution (incl. two 1-channel peri-
ment media and b) sucking from a heated con- staltic pumps, 3-part acrylic glass container
tainer not to lower the media temperature inside and replacement-/dilution routine)
the test station by cold replacement media. 15-2x7-x2xx

In standard configuration the 7 filling-tubes are Additional price for Titanium filling tubes
made of 316 stainless steel but also are avail- (instead 316 stainless steel); for FRL 720
able from Titanium to eliminate any possibility 15-207-xx1x
of corrosion even inside the tubes.
Additional price for Titanium filling tubes
For 8-channel operation the FRL 820, for 14- (instead 316 stainless steel); for FRL 820
channel operation the FRL 720-2 are available. 15-208-xx1x
In combination with an ERWEKA SP syringe
Additional price for Titanium filling tubes
pump and an optional 3-part container (instead
(instead 316 stainless steel); for FRL 720-2
standard 2-part) the Autosampler 720 allows
15-214-xx1x
dilution of the collected samples with an accu-
racy of 0.1 ml. Therefore, in combination with

31
2.2. Autosampler, FRL 724
7-, 8- or 14-channel Autosampler with in-
tegrated valves

The 7-channel FRL 724 with one solenoid The medium replacement (if equipped) is per-
3-way-valve per channel and x/y-driven sam- formed by a 2-part container of which the re-
pling arm was designed for silent operation placement media section is constantly refilled
and maximum corrosion resistance in combina- by two 1-channel peristaltic pumps from an
tion with either the peristaltic- or piston pump external heated or unheated flask. This feature
for stirrer type dissolution testers as well as in permits a) nearly unlimited amount of replace-
combination with an USP 4 Offline system. ment media and b) sucking from a heated con-
tainer not to lower the media temperature inside
To archive silent operation as well as corrosion the test station by cold replacement media.
resistance, the unit is mainly made from corro- 15-207-2000
sion free materials such as alloy and plastics
and features a gentle and precise spindle drive.

The integrated 3-way solenoid valves, in com- Additional price 8-channel version, FRL 824
bination with a stirrer-type dissolution system 15-208-2000
allow accurate dosing ( 0.5 ml) when using
peristaltic- or piston pump. The medium is Additional price 14-channel version,
pumped in a close loop from the vessel back to FRL 724-2 15-214-2000
the vessel until the tubing is completely filled
and only then the valve switched to collect the Additional price media replacement (incl. two
sample into glass tubes or HPLC vials. 1-channel peristaltic pumps, 2-part acrylic
In combination with an USP 4 Flow-Through- glass container and replacement routine)
Cell Offline System the 3-way-valves operate 15-208-x1xx
as a splitter to collect an average of the flow-
through. The spindle drive, especially with USP Additional price for Titanium filling tubes
4 systems, is a big advantage since the arm of (instead 316 stainless steel); for FRL 724
the Autosampler can be precisely moved from 15-207-xx1x
row to row without returning to the zero-position
in between. Additional price for Titanium filling tubes
(instead 316 stainless steel); for FRL 824
The alloy rack-holder is made to carry various 15-208-xx1x
racks (glass tubes of 10 ml and 25 ml capacity
as well as HPLC vials of 1.5 ml and 4.0 ml Additional price for Titanium filling tubes
maximum volume) to store max. 25 sampling (instead 316 stainless steel); for FRL 724-2
intervals of 8 vessels or 12 sampling intervals of 15-214-xx1x
14 test stations (FRL 724-2 version to operate
with DT 1420). For temperature sensitive sam-
ples a cooled rack for HPLC vials is available.

HPLC membrane piercing is realised by using a

nd
2 spindle drive of the y-axis of the sampling
arm. The high-torque gear allows piercing of
either split- or even none-split septum.

32
Options 3.1. Filter Changer, AFC 825
(8-channel membrane filter changer)
2.3 Racks for Autosampler

Rack for 25x 8, for HPLC vials of 1.5 ml

volume 81-200-0001

Rack for 25x 8, for HPLC vials of 4.0 ml

volume 81-200-0002
The automated ERWEKA Filter Change Station
Rack for 24x 8, with glass tubes of 10 ml AFC 825 was specially designed for Dissolution
volume 81-200-0003 Offline and UV/HPLC Online Systems to
change filters after or during the test run auto-
Rack for 17x 8, with glass tubes of 25 ml matically. Changing filters during the test pro-
volume 81-200-0004 cedure (i.e. after each sampling interval) is es-
sential when the withdrawn media trends to
block the filters. The ERWEKA AFC 825 in-
2.4 Heating device for the substi- cludes a magazine for up to 8x 25 filter holders
tute media for membrane filters.
In order to stay within the temperature tolerance
when replacing large quantities of media, it is 100 240 Volt, 50/60Hz 12-085-0825
necessary to use pre-heated media. The
ERWEKA heating device allows a temperature-
controlled pre-heating of the media, before it is 3.2. Filter Changer AFC 825
pumped into the media replacement container.
with 3 way-valves
Separate container with approx. 4.000 ml
The use of 3 way-valves enables the user to
vessel for pre heated media reservoir.
bypass the filter system, when required (e.g. for
- Thermostat for keeping the required temp.
media replacement). Additional price
of 37 C, accuracy + - 0,5 C, within the con-
tainer.
AFC 825 - 16 V (for 8 stations)
- Retrofitting the fraction collector with the
100 - 240 Volt; 50/60 Hz 82-085-0826
Peristaltic Pump. Reworking the housing,
connecting tubing etc.
AFC 825 14 V (for 7 stations)
- Changed the PCB within the fraction collec-
100 - 240 Volt; 50/60 Hz 82-085-0827
tor.
- EPROM update in the Dissolution tester.
AFC 825 12 V (for 6 stations)
80-20x-2000
100 - 240 Volt; 50/60 Hz 82-085-0828

Temperature documentation at the DT (of Options

the pre-heated substitute media)
80-20x-2001 200 pcs. of 1.0 m membrane filters ROBY
Dissolution Systems including filter holders 82-085-0101

200 pcs. of 0.70 m membrane filters ROBY

including filter holders 82-085-0102

200 pcs. of 0,45 m membrane filters ROBY

including filter holders 82-085-0103

33
4. Automatic pH Changer, 7. UV-VIS Spectrophotometer
AMC-A (only)

ERWEKA SPM-8, Dissolution ready

70-209-9000

ERWEKA SPM-16, Dissolution ready

70-209-9002
The AMC-A is a device for the automated pH
change according to USP method A (half-
change).
The accurate amount (volume) of buffer solu-
tion is dosed into the 8 glass vessels (max. 250
ml capacity) which are located inside a thermo-
statically heated acrylic water bath.
In combination with the DT 820 where the pH
change time point is set/programmed the op- Perkin Elmer Lambda 25-8, Win Lab 2
eration is fully automated: the stirring action is 70-204-9000
stopped and the 8 pumps, integrated into the
AMC-A, transfer the buffer solution from the Perkin Elmer Lambda 25-8, Win Lab 5
AMC-A into the vessels of the Dissolution 70-204-9001
Tester. When the pre-set time limit of pH
change is reached (default setting 5 minutes Perkin Elmer Lambda 25-16, Win Lab 2
according to USP) the stirring action is re- 70-204-9002
started.
Using any other Dissolution Tester the opera- Perkin Elmer Lambda 25-16, Win Lab 5
tion is semi-automatic. The stirring action has to 70-204-9003
be stopped, by pressing a knob at the AMC-A
the buffer solution transfer is started and when Perkin Elmer Lambda 35-8, Win Lab 5
the pH change time limit is reached the stirring 70-204-9004
action has to be re-started.
Perkin Elmer Lambda 35-16, Win Lab 5
230V/50Hz 80-xx0-x001 70-204-9005
230V/60Hz 80-xx0-x002
115V/60Hz 80-xx0-x003 70-205-9005
127V/60Hz 80-xx0-x004 Shimadzu 1800

5. Computer
PC with 17 TFT monitor, colour printer etc.
70-203-5555 70-207-9000
Agilent 8453,
Dissolution-ready
6. System Software
[Link] (UV-VIS Online, Perkin Elmer and
Shimadzu only) 51-203-0000
70-208-9000
Analytic Jena Specord 205, Dissolution
ready

34
8. Tubing + Connectors
Tubing + Connectors UV-VIS Online
70-20x-0001

Tubing + Connectors UV VIS Dual Online

70-20x-0002

Tubing + Connectors UV VIS Off-/Online

70-20x-0003

9. Pre Configuration
Pre Configuration Offline, with FRL 720
70-xxx-0000

Pre Configuration Offline, with FRL 724

70-xxx-0000

Pre Configuration Offline, with FRL 720-2

70-xxx-0000

Pre Configuration Offline, with FRL 724-2

70-xxx-0000

Pre Configuration Dual Offline

70-xxx-0000

Pre Configuration UV-VIS Online

70-20x-0004

Pre Configuration UV-VIS Dual Online

70-20x-0005

Pre Configuration UV-VIS Off-/Online

70-20x-0006

[Link] Box
Valve Box for UV-VIS Off-/Online

230V/50Hz 80-206-0001
230V/60Hz 80-206-0002
115V/60Hz 80-206-0003
127V/60Hz 80-206-0004

35
Dissolution Offline-Kits

BUDGET Kit
(storage/doses into tubes only)

The BUDGET Offline Kit with fixed stainless For more precise dosing after collection the
steel sample withdraw tubes to collect into x/y driven arm moves down to a selected sam-
glass tubes of 10 ml or 25 ml is designed to ple volume level and pumps back the sample
serve those customers with a limited budget above this level to the dissolution vessel (over-
and comprises of filling/levelling principle).
1.) 7 stainless steel (316), electro polished,
height adjustable sampling tubes (fix inside To minimize cross-contamination between of
the medium) with external holder for filters the media of various sampling intervals there is
2.) 8-channel Peristaltic pump with Verder- an automated tube cleaning routine between
prene tubing and RS 232 interface for ex- the sampling intervals.
ternal control
3.) FRL 720 7-channel silent Autosampler BUDGET Offline Kit, 7-channel
with x/y driven arm in corrosion reduced 15-107-0000
design for collection of up to 25 sampling
intervals into 10 ml glass tubes or 17 sam-
pling intervals into 25 ml glass tubes as
well as support arm to hold a rack.
4.) Tubing/Connector Kit, Teflon
5.) System pre-configuration Additional price for 8-channel version
6.) Upgraded micro-controller for DT 820 se- 15-1x8-xxxx
ries to control the complete Offline System
Additional price for Titanium sample with-
Not included: DT 820 dissolution tester and draw tubes, instead stainless steel
collection rack (for glass tubes only) 15-xxx-1xxx

Operation principle: Additional price for Titanium collection tubes

The stainless steel (optional Titanium) sample in the Autosampler, instead [Link]
withdraw tubes are fix installed inside the ves- 15-xxx-x2xx
sel and can be manually height adjusted (mid-
way between the top of the media and the top Rack for holding 25x 8 glass tubes, 10 ml
of the rotating basket or paddle). For filtration 81-200-0003
purposes a filter can be inserted into a filter
holder positioned at the connection of sample Rack for holding 17x 8 glass tubes, 25 ml
withdraw tube and Teflon system tubing thus to 81-200-0004
minimize influences to the hydrodynamics in-
side the vessel. Glass tubes, 10 ml (100 pcs.)
91-200-0003
The connected pump (8-channel peristaltic
pump) transfers the sample to collect from the Glass tubes, 25 ml (100 pcs.)
vessel into glass tubes (10 ml or 25 ml maxi- 91-200-0004
mum capacity) positioned in the rack at the
Autosampler.

36
BASE Kit
(storage/doses into tubes only)

The BASE Offline Kit represents the basic The connected pump (8-channel peristaltic
USP/EP compliant ERWEKA offline system pump) transfers the sample to collect from the
where the stainless steel (316) sample with- vessel into glass tubes (10ml or 25 ml maxi-
draw tubes are driven into the media, to the mum capacity) positioned in the rack at the
exact USP/EP sampling height, only while the Autosampler.
sample is withdrawn not to change the hydro-
dynamics constantly. For more precise dosing after collection the
Similar to the BUDGET version also this ver- x/y driven arm moves down to a selected sam-
sion allows collecting into glass tubes of 10 ml ple volume level and pumps back the sample
or 25ml and media replacement is available as above this level to the dissolution vessel (over-
an option. The system comprises of: filling/levelling principle).
1.) Fully USP/EP compliant sampling station
with automatic sample withdraw height ad- To minimize cross-contamination between of
justment and 7 stainless steel (316) sam- the media of various sampling intervals theres
ple withdraw tubes an automated tube cleaning routine between
2.) 8-channel Peristaltic pump with Verder- the sampling intervals.
prene tubing and RS 232 interface for ex-
ternal control BASE Offline Kit, 7-channel
3.) FRL 720 7-channel silent Autosampler 15-117-0000
with x/y driven arm in corrosion reduced
design for collection of up to 25 sampling
intervals into 10 ml glass tubes or 17 sam-
pling intervals into 25 ml glass tubes as
well as support arm to hold a rack.
4.) Tubing/Connector Kit, Teflon
5.) System pre-configuration
6.) Upgraded micro-controller for DT 820 se-
ries to control the complete Offline System

Not included: DT 820 dissolution tester and

collection rack (for glass tubes only).

Operation principle:
The stainless steel (optional Titanium) sample
withdraw tubes are driven into the media (ex-
actly midway between the top of the media and
the top of the rotating Basket or Paddle) only
while the sample is withdrawn not to change
the hydrodynamic inside the vessel as de-
scribed in the USP and EP.

Optional the sample withdraw system can be

equipped with electronic temperature sensors
for each vessel to archive media temperature
documentation for each test-station.

37
 Additional price for 8-channel version
15-118-xxxx

Additional price for Titanium sample with-

draw tubes, instead of stainless steel
15-2xx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead of [Link]
15-2xx-x2xx

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test-station
15-2xx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Glass tubes, 25 ml (100 pcs.)

91-200-0004

38
PRECISION/lq Kit
(storage/precision doses into tubes & HPLC vials, media replacement and HPLC vial
membrane piercing)

The PRECISION/lq Offline Kit represents the The connected 7-channel syringe Pump SP
standard USP/EP compliant ERWEKA Offline 725/10 sucks the media through the filter and
system with high precision dosing ( 0.1 ml), Teflon tubing to the syringe, passing a motor
standard media replacement, HLPC Vial mem- driven, mechanical 4-way switching valve with
brane piercing and optional dilution function. inert interior. Then the valves switch and the
The system comprises of: new Teflon coated, 2-part pistons push the
1.) Fully USP/EP compliant sampling station sample into the waiting glass tubes or
with automatic sample withdraw height ad- sealed/unsealed HPLC vials (membrane pierc-
justment and 7 stainless steel (316) sam- ing standard).
ple withdraw tubes
2.) 7-channel syringe pump SP 725/10 with 10 The FRL 720 Autosampler allows storage of up
ml syringes and mechanically operated to 25 (glass tubes of 10 ml-, HPLC vials of 1.5
valves or 4.0 ml capacity) or 17 (glass tubes of 25 ml
3.) FRL 720 7-channel silent Autosampler capacity) sampling intervals.
with x/y driven arm in corrosion reduced
design for collection of up to 25 sampling Optionally cooled racks for HPLC vials are
intervals into 10 ml glass tubes, sealed available. After sample collection the 316
1.2/4.0 ml HPLC vials or 17 sampling in- stainless steel tubes (optionally Titanium) of the
tervals into 25 ml glass tubes as well as Autosampler drive down into the replacement
support arm to hold a rack. media inside the acrylic glass reservoir which
4.) Tubing/Connector Kit, Teflon refills after each media replacement interval
5.) System pre-configuration automatically by two integrated 1-channel peri-
6.) Upgraded micro-controller for DT 820 se- staltic pumps. The syringes will transfer the
ries to control the complete Offline System desired volume to the test-stations to keep the
media volume within the USP/EP specified
Not included: DT 820 dissolution tester and 1% limits.
collection rack.
The FRL 720 in combination with the syringe
Operation principle: pump and 10/25 ml glass tubes allows auto-
The stainless steel (optional Titanium) sample mated dilution of the sample in the 1:1, 1:2, 1:5
withdraw tubes are driven into the media (ex- and 1:10 relations.
actly midway between the top of the media and
the top of the rotating Basket or Paddle) only PRECISION/lq Offline Kit, 7-channel
while the sample is withdrawn not to change 15-127-0000
the hydrodynamic inside the vessel as de-
scribed in the USP and EP.

Optional the sample withdraw system can be

equipped with electronic temperature sensors
for each vessel to archive media temperature
documentation for each test-station.

39
 Additional price for 8-channel version
15-128-xxxx

Additional price for Titanium sample with-

draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead [Link]
15-xxx-x2xx

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test station
15-xxx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 25 ml (100 pcs.)

91-200-0004

Rack for holding 25x 8 vials, 1.5 ml

81-200-0001

Rack (cooled) for holding 25x 8 vials, 1.5 ml

81-200-0011

Rack for holding 25x 8 vials, 4.0 ml

81-200-0002

Rack (cooled) for holding 25x 8 vials, 4.0 ml

81-200-0012

Dilution option, incl. 3-part container

81-207-0020

40
PRECISION/hq Kit
(storage/precision doses into tubes & HPLC Vials, media replacement and HPLC
Vial membrane piercing)

The PRECISION/hq Offline Kit, in contrast to Optional the sample withdraw system can be
the PRECISION/lq Kit, due to the higher ca- equipped with electronic temperature sensors
pacity 25 ml syringes (dosing precision 0.25 for each vessel to archive media temperature
ml), allows withdrawing/storing higher volume of documentation for each test-station.
sample within a shorter time. E.g. when more
than 7 ml media has to be collected the The connected 7-channel syringe Pump SP
PRECISION/lq Kit needs to withdraw media 725/25 sucks the media through the filter and
twice while the PRECISION/hq Kit can with- Teflon tubing to the syringe, passing a motor
draw up to 20 ml at once. The system com- driven, mechanical 4-way switching valve with
prises of: inert interior. Then the valves switch and the
1.) Fully USP/EP compliant sampling station new Teflon coated, 2-part pistons push the
with automatic sample withdraw height ad- sample into the waiting glass tubes or
justment and 7 stainless steel (316) sam- sealed/unsealed HPLC vials (membrane pierc-
ple withdraw tubes ing standard).
2.) 7-channel syringe pump SP 725/25 with 25
ml syringes and mechanically operated The FRL 720 Autosampler allows storage of up
valves to 25 (glass tubes of 10 ml-, HPLC vials of 1.5
3.) FRL 720 7-channel silent Autosampler or 4.0 ml capacity) or 17 (glass tubes of 25 ml
with x/y driven arm in corrosion reduced capacity) sampling intervals.
design for collection of up to 25 sampling
intervals into 10 ml glass tubes, sealed Optionally cooled racks for HPLC vials are
1.2/4.0 ml HPLC vials or 17 sampling in- available.
tervals into 25 ml glass tubes as well as
support arm to hold a rack. After sample collection the 316 stainless steel
4.) Tubing/Connector Kit, Teflon tubes (optionally Titanium) of the Autosampler
5.) System pre-configuration drive down into the replacement media inside
6.) Upgraded micro-controller for DT 820 se- the acrylic glass reservoir which refills after
ries to control the complete Offline System each media replacement interval automatically
by two integrated 1-channel peristaltic pumps.
Not included: DT 820 dissolution tester and The syringes will transfer the desired volume to
collection rack. the test-stations to keep the media volume
within the USP/EP specified 1% limits.
Operation principle:
The stainless steel (optional Titanium) sample The FRL 720 in combination with the syringe
withdraw tubes are driven into the media (ex- pump and 10/25 ml glass tubes allows auto-
actly midway between the top of the media and mated dilution of the sample in the 1:1, 1:2, 1:5
the top of the rotating Basket or Paddle) and 1:10 relations.
only while the sample is withdrawn not to
change the hydrodynamic inside the vessel PRECISION/hq Offline Kit, 7-channel
as described in the USP and EP. 15-147-0000

41
 Additional price for 8-channel version
15-138-xxxx

Additional price for Titanium sample with-

draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead [Link]
15-xxx-x2xx

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test-station
15-xxx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 25 ml (100 pcs.)

91-200-0004

Rack for holding 25x 8 vials, 1.5 ml

81-200-0001

Rack (cooled) for holding 25x 8 vials, 1.5 ml

81-200-0011

Rack for holding 25x 8 vials, 4.0 ml

81-200-0002

Rack (cooled) for holding 25x 8 vials, 4.0 ml

81-200-0012

Dilution option, incl. 3-part container

81-207-0020

42
FAST Kit
(storage/doses into tubes & HPLC vials, media replacement and HPLC vial mem-
brane piercing)

The dosing-by-valves FAST Kit offers best Optional the sample withdraw system can be
possible dosing results in combination with the equipped with electronic temperature sensors
easy-to-use, budget 8-channel peristaltic pump for each vessel to archive media temperature
in combination with short sampling intervals documentation for each test-station.
(from 2 minutes).
During the sample withdraw tubes are inside
The system allows precision sample dosing into the media the peristaltic pump pumps the me-
glass tubes (10 ml/25 ml) or sealed/unsealed dia in a cycle from the vessel through the Auto-
HPLC vials (1.5 ml/4.0 ml), accurate media sampler back to the vessel until all air inside the
replacement as well as HPLC membrane pierc- tubing system is removed and the filters are
ing. The system comprises of: saturated.
1.) Fully USP/EP compliant sampling station
with automatic sample withdraw height ad- Then the 3-way solenoid valves inside the arm
justment and 7 stainless steel (316) sam- of the FRL 724 Autosampler switch and the
ple withdraw tubes required amount of media is collected in either
2.) 8-channel peristaltic pump with Verder- glass tubes (10/25 ml) or sealed/unsealed
prene tubing HPLC vials (1.5/4.0 ml) with an accuracy of
3.) FRL 724 7-channel silent Autosampler 0.5 ml.
with 7x 3-way-valves and x/y driven arm in
corrosion reduced design for collection of Optionally cooled racks for HPLC vials are
up to 25 sampling intervals into 10 ml glass available.
tubes, sealed 1.2/4.0 ml HPLC vials or 17
sampling intervals into 25 ml glass tubes After sample collection the 316 stainless steel
as well as support arm to hold a rack. tubes (optionally Titanium) of the Autosampler
4.) Tubing/Connector Kit, Teflon drive to and into the replacement media inside
5.) System pre-configuration the acrylic glass reservoir which refills after
6.) Upgraded micro-controller for DT 820 se- each media replacement interval automatically
ries to control the complete Offline System by two integrated 1-channel peristaltic pumps.
The 8-channel peristaltic pump will transfer the
Not included: DT 820 dissolution tester and desired volume to the test-stations (vessels) to
collection rack keep the media volume within the USP/EP
specified 1% limits.
Operation principle:
The stainless steel (optional Titanium) sample FAST Offline Kit, 7-channel
withdraw tubes are driven into the media (ex- 15-157-0000
actly midway between the top of the media and
the top of the rotating Basket or Paddle) only
while the sample is withdrawn not to change
the hydrodynamic inside the vessel as de-
scribed in the USP and EP.

43
 Additional price for 8-channel version
15-148-xxxx

Additional price for Titanium sample with-

draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection

tubes in the Autosampler, instead [Link]
15-xxx-x2xx

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test-station
15-xxx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 25 ml (100 pcs.)

91-200-0004

Rack for holding 25x 8 vials, 1.5 ml

81-200-0001

Rack (cooled) for holding 25x 8 vials,

1.5 ml 81-200-0011

Rack for holding 25x 8 vials, 4.0 ml

81-200-0002

Rack (cooled) for holding 25x 8 vials,

4.0 ml 81-200-0012

44
POWER Kit
(storage/doses into tubes & HPLC vials, media replacement, HPLC vial membrane
piercing, filtration from 0.22 m)

The dosing-by-valves POWER Kit represents Optional the sample withdraw system can be
the high-end ERWEKA Offline Kit which offers equipped with electronic temperature sensors
features such as membrane filtration from as for each vessel to archive media temperature
low as 0.22 m, precision dosing (better 0.5 documentation for each test-station.
ml without regular pump-channel calibra-
tion/adjustment) and extremely short sampling During the sample withdraw tubes are inside
intervals (from 2 minutes). the media the piston pump pumps the media in
a cycle from the vessel through the membrane
The system collects into glass tubes (10 ml/25 filter (optional) through the Autosampler back to
ml) or sealed/unsealed HPLC vials (1.5 ml/4.0 the vessel, until all air inside the tubing system
ml) and offers accurate media replacement as is removed and the filters are saturated.
well as HPLC membrane piercing. The system
comprises of: Then the 3-way solenoid valves inside the arm
1.) Fully USP/EP compliant sampling station of the FRL 724 Autosampler switch and the
with automatic sample withdraw height ad- required amount of media is collected in either
justment and 7 stainless steel (316) sam- glass tubes (10/25 ml) or sealed/unsealed
ple withdraw tubes HPLC vials (1.5/4.0 ml) with an accuracy of
2.) 7-channel, valve-free piston pump with better 0.5 ml.
Teflon/Ceramic pump-heads
3.) FRL 724 7-channel silent Autosampler The FRL 724 Autosampler allows storage of up
with 7x 3-way-valves and x/y driven arm in to 25 (glass tubes of 10 ml-, HPLC vials of 1.5
corrosion reduced design for collection of or 4.0 ml capacity) or 17 (glass tubes of 25 ml
up to 25 sampling intervals into 10 ml glass capacity) sampling intervals.
tubes, sealed 1.2/4.0 ml HPLC vials or 17
sampling intervals into 25 ml glass tubes Optionally cooled racks for HPLC vials are
as well as support arm to hold a rack. available.
4.) Tubing/Connector Kit, Teflon
5.) System pre-configuration After sample collection the 316 stainless steel
6.) Upgraded micro-controller for DT 820 se- tubes (optionally Titanium) of the Autosampler
ries to control the complete Offline drive to and into the replacement media inside
the acrylic glass reservoir which refills after
Not included: DT 820 dissolution tester and each media replacement interval automatically
collection rack by two integrated 1-channel peristaltic pumps.
The piston pump will transfer the desired vol-
Operation principle: ume to the test-stations to keep the media vol-
The stainless steel (optional Titanium) sample ume within the USP/EP specified 1% limits.
withdraw tubes are driven into the media (ex-
actly midway between the top of the media and POWER Offline Kit, 7-channel
the top of the rotating Basket or Paddle) only 15-167-0000
while the sample is withdrawn not to change
the hydrodynamic inside the vessel as de-
scribed in the USP and EP.

45
 Additional price for 8-channel version
15-158-xxxx

Additional price for Titanium sample with-

draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead [Link]
15-xxx-x2xx

7/8 channel Double-Filtration-System to

insert membrane filters from 0.22 m (pre-
filtration required) 81-207-0800

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test-station
15-xxx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 25 ml (100 pcs.)

91-200-0004

Rack for holding 25x 8 vials, 1.5 ml

81-200-0001

Rack (cooled) for holding 25x 8 vials, 1.5 ml

81-200-0011

Rack for holding 25x 8 vials, 4.0 ml

81-200-0002

Rack (cooled) for holding 25x 8 vials, 4.0 ml

81-200-0012

46
BASE-14 Kit
(storage/doses into tubes only)

The BASE-14 Offline Kit represents the basic Optional the sample withdraw system can be
USP/EP compliant ERWEKA offline system for equipped with electronic temperature sensors
14 test-stations where the stainless steel (316) for each vessel to archive media temperature
sample withdraw tubes are driven into the me- documentation for each test-station.
dia, to the exact USP/EP sampling height, only
while the sample is withdrawn not to change The connected pump (16-channel peristaltic
the hydrodynamics constantly. pump) transfers the sample to collect from the
The BASE-14 version allows collecting into vessel into glass tubes (10ml or 25 ml maxi-
glass tubes of 10 ml or 25ml. mum capacity) positioned in the rack at the
Autosampler.
The system comprises of:
1.) Fully USP/EP compliant sampling station For more precise dosing after collection the
with automatic sample withdraw height ad- x/y driven arm moves down to a selected sam-
justment and 14 stainless steel (316) sam- ple volume level and pumps back the sample
ple withdraw tubes above this level to the dissolution vessel (over-
2.) 16-channel peristaltic pump with verder- filling/levelling principle).
prene tubing
3.) FRL 720-2 14-channel silent Autosampler To minimize cross-contamination between of
with x/y driven arm in corrosion reduced the media of various sampling intervals theres
design for collection of up to 12 sampling an automated tube cleaning routine between
intervals into 10 ml glass tubes or 8 sam- the sampling intervals.
pling intervals into 25 ml glass tubes as
well as support arm to hold a rack. BASE-14 Offline Kit, 14-channel
4.) Tubing/Connector Kit, Teflon 16-128-0000
5.) System pre-configuration
6.) Upgraded DT 1420i series to control the
complete Offline System, incl. alpha-
numeric keypad, graphic LC display and
product memory

Not included: DT 1420 dissolution tester and

collection rack (for glass tubes only)

Operation principle:
The stainless steel (optional Titanium) sample
withdraw tubes are driven into the media (ex-
actly midway between the top of the media and
the top of the rotating Basket or Paddle) only
while the sample is withdrawn not to change
the hydrodynamic inside the vessel as de-
scribed in the USP and EP.

47
 Additional price for Titanium sample with-
draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead [Link]
15-xxx-x2xx

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test-station
15-xxx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 25 ml (100 pcs.)

91-200-0004

48
FAST-14 Kit
(storage/doses into tubes & HPLC vials, media replacement and HPLC vial mem-
brane piercing)

The dosing-by-valves FAST-14 Kit offers best Optional the sample withdraw system can be
possible dosing results in combination with the equipped with electronic temperature sensors
easy-to-use, budget 16-channel peristaltic for each vessel to archive media temperature
pump in combination with short sampling inter- documentation for each test-station.
vals (from 2 minutes).
During the sample withdraw tubes are inside
The system allows precision sample dosing into the media the peristaltic pump pumps the me-
glass tubes (10 ml / 25 ml) or sealed/unsealed dia in a cycle from the vessel through the Auto-
HPLC vials (1.5 ml/4.0 ml), accurate media sampler back to the vessel, until all air inside
replacement as well as HPLC membrane pierc- the tubing system is removed and the filters are
ing. The system comprises of: saturated.
1.) Fully USP/EP compliant sampling station
with automatic sample withdraw height ad- Then 3-way solenoid valves inside the arm of
justment and 14 stainless steel (316) sam- the FRL 724-2 Autosampler switch and the
ple withdraw tubes required amount of media is collected in either
2.) 16-channel peristaltic pump with Verder- glass tubes (10/25 ml) or sealed/unsealed
prene tubing HPLC vials (1.5/4.0 ml) with an accuracy of
3.) FRL 724-2 14-channel silent Autosampler 0.5 ml.
with 14x 3-way-valves and x/y driven arm
in corrosion reduced design for collection Optionally cooled racks for HPLC vials are
of up to 12 sampling intervals into 10 ml available.
glass tubes, sealed 1.2/4.0 ml HPLC vials
or 8 sampling intervals into 25 ml glass After sample collection the 316 stainless steel
tubes as well as support arm to hold a tubes (optionally Titanium) of the Autosampler
rack. drive to and into the replacement media inside
4.) Tubing/Connector Kit, Teflon the acrylic glass reservoir which refills after
5.) System pre-configuration each media replacement interval automatically
6.) Upgraded DT 1420i series to control the by two integrated 1-channel peristaltic pumps.
complete Offline System, incl. alpha- The syringes will transfer the desired volume to
numeric keypad, graphic LC display and the test-stations to keep the media volume
product memory within the USP/EP specified 1% limits.

Not included: DT 1420 dissolution tester and FAST-14 Offline Kit, 14-channel
collection rack 16-148-0000

Operation principle:
The stainless steel (optional Titanium) sample
withdraw tubes are driven into the media (ex-
actly midway between the top of the media and
the top of the rotating Basket or Paddle)
only while the sample is withdrawn not to
change the hydrodynamic inside the vessel
as described in the USP and EP.

49
 Additional price for Titanium sample with-
draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead [Link]
15-xxx-x2xx

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 25 ml (100 pcs.)

91-200-0004

Rack for holding 25x 8 vials, 1.5 ml

81-200-0001

Rack (cooled) for holding 25x 8 vials, 1.5 ml

81-200-0011

Rack for holding 25x 8 vials, 4.0 ml

81-200-0002

Rack (cooled) for holding 25x 8 vials, 4.0 ml

81-200-0012

50
POWER-14 Kit
(storage/doses into tubes & HPLC vials, media replacement, HPLC vial membrane
piercing, filtration from 0.22 m)

The dosing-by-valves POWER-14 Kit repre- Optional the sample withdraw system can be
sents the high-end ERWEKA Offline Kit which equipped with electronic temperature sensors
offers features such as membrane filtration from for each vessel to archive media temperature
as low as 0.22 m, precision dosing (better documentation for each test-station.
0.5 ml without regular pump-channel calibra-
tion/adjustment) and extremely short sampling During the sample withdraw tubes are inside
intervals (from 2 minutes). the media the piston pump pumps the media in
a cycle from the vessel through the Autosam-
The system collects into glass tubes (10 ml/25 pler back to the vessel, until all air inside the
ml) or sealed/unsealed HPLC vials (1.5 ml/4.0 tubing system is removed.
ml) and offers accurate media replacement as
well as HPLC membrane piercing. The system Then 3-way solenoid valves inside the arm of
comprises of: the FRL 724-2 Autosampler switch and the
1.) Fully USP/EP compliant sampling station required amount of media is collected in either
with automatic sample withdraw height ad- glass tubes (10/25 ml) or sealed/unsealed
justment and 14 stainless steel (316) sam- HPLC vials (1.5/4.0 ml) with an accuracy of
ple withdraw tubes better 0.5 ml.
2.) 2x 7-channel, valve-free piston pump with
Teflon/Ceramic pump-heads Optionally cooled racks for HPLC vials are
3.) FRL 724-2 14-channel silent Autosampler available.
with 14x 3-way-valves and x/y driven arm
in corrosion reduced design for collection After sample collection the 316 stainless steel
of up to 12 sampling intervals into 10 ml tubes (optionally Titanium) of the Autosampler
glass tubes, sealed 1.2/4.0 ml HPLC vials drive to and into the replacement media inside
or 8 sampling intervals into 25 ml glass the acrylic glass reservoir which refills after
tubes as well as support arm to hold a each media replacement interval automatically
rack. by two integrated 1-channel peristaltic pumps.
4.) Tubing/Connector Kit, Teflon The piston pump will transfer the desired vol-
5.) System pre-configuration ume to the test-stations to keep the media vol-
6.) Upgraded DT 1420i series to control the ume within the USP/EP specified 1% limits.
complete Offline System, incl. alpha-
numeric keypad, graphic LC display and POWER-14 Offline Kit, 14-channel
product memory 16-158-0000

Not included: DT 1420 dissolution tester and

collection rack.

Operation principle:
The stainless steel (optional Titanium) sample
withdraw tubes are driven into the media (ex-
actly midway between the top of the media and
the top of the rotating Basket or Paddle) only
while the sample is withdrawn not to change
the hydrodynamic inside the vessel as de-
scribed in the USP and EP.

51
 Additional price for Titanium sample with-
draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead [Link]
15-xxx-x2xx

14 channel Double-Filtration-System to
insert membrane filters from 0.22 m (pre-
filtration required) 81-207-1400

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test-station
15-xxx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 25 ml (100 pcs.)

91-200-0004

Rack for holding 25x 8 vials, 1.5 ml

81-200-0001

Rack (cooled) for holding 25x 8 vials, 1.5 ml

81-200-0011

Rack for holding 25x 8 vials, 4.0 ml

81-200-0002

Rack (cooled) for holding 25x 8 vials, 4.0 ml

81-200-0012

52
DUAL Kit
(storage/precision doses into tubes & HPLC Vials, media replacement and HPLC
Vial membrane piercing- from 2 Dissolution baths)

The DUAL Offline Kit is designed to collect point, drop the tablets, start the stirring action
samples from 2 independent operation dissolu- etc.
tion testers which are running with the same
product/media but e.g. with different batches. For sampling the stainless steel (optional Tita-
The samples from both baths are withdrawn by nium) sample withdraw tubes are driven into the
only one SP 725/25 syringe pump and collected media (exactly midway between the top of the
into just one Autosampler. media and the top of the rotating Basket or
Therefore the maximum capacity is 12 sampling Paddle) only while the sample is withdrawn
intervals. In case of sampling intervals not to change the hydrodynamic inside the ves-
equal/greater 15 min. (incl. media replacement) sel as described in the USP and EP.
both baths run simultaneously, in case of
shorter sampling intervals one after the other. Optional the sample withdraw systems can be
Minimum sampling interval of 15 minutes. The equipped with electronic temperature sensors
system comprises of: for each vessel to archive media temperature
1.) 2x fully USP/EP compliant sampling station documentation for each test-station.
with automatic sample withdraw height ad-
justment and 7 stainless steel (316) sam- The connected 7-channel syringe Pump SP
ple withdraw tubes each 725/25 sucks the media through the filter and
2.) 2x autom. tablet insert system Teflon tubing inside the syringe, passing a mo-
3.) 7-channel syringe pump SP 725/25 with 25 tor driven, mechanical 4-way switching valve
ml syringes and mechanically operated with inert interior. Then the valves switch and
valves the new Teflon coated, 2-part pistons push the
4.) FRL 720 7-channel silent Autosampler sample into the waiting glass tubes or
with x/y driven arm in corrosion reduced sealed/unsealed HPLC vials (membrane pierc-
design for collection of up to 12 sampling ing standard).
intervals/bath into 10 ml glass tubes,
sealed 1.2/4.0 ml HPLC vials or 8 sampling Optionally cooled racks for HPLC vials are
intervals/bath into 25 ml glass tubes as available.
well as support arm to hold a rack.
5.) 2x Tubing/Connector Kit, Teflon After sample collection the 316 stainless steel
6.) System pre-configuration tubes (optionally Titanium) of the Autosampler
7.) 2x upgraded micro-controller for DT 820 drive down into the replacement media inside
series to control the complete Offline Sys- the acrylic glass reservoir which refills after
tem each media replacement interval automatically
by two integrated 1-channel peristaltic pumps.
Not included: 2x DT 820 dissolution tester and The syringes will transfer the desired volume to
collection rack (for glass tubes only). the test-stations to keep the media volume
within the USP/EP specified 1% limits but
Operation principle: also to clean the complete tubing/valve/syringe
After entering all test information the time man- system for the next sample
agement will calculate if the tests in both baths withdraw process at the other bath, to minimize
can be operated at the same time or only after the cross-contamination between the 2 dissolu-
each other. The time management will calculate tion testers.
when to drop the tablets best and the automati-
cally start each test-run at the optimum time DUAL Offline Kit, 2x 7-channel
15-177-0000

53
 Additional price for 2x 8-channel version
15-168-xxxx

Additional price for Titanium sample with-

draw tubes, instead stainless steel
15-xxx-1xxx

Additional price for Titanium collection tubes

in the Autosampler, instead [Link]
15-xxx-x2xx

Additional price for electronic temperature

sensors for media temperature measure-
ment/documentation in each test-station
15-xxx-xx1x

Rack for holding 25x 8 glass tubes, 10 ml

81-200-0003

Rack for holding 17x 8 glass tubes, 25 ml

81-200-0004

Glass tubes, 10 ml (100 pcs.)

91-200-0003

Glass tubes, 25 ml (100 pcs.)

91-200-0004

Rack for holding 25x 8 vials, 1.5 ml

81-200-0001

Rack (cooled) for holding 25x 8 vials, 1.5 ml

81-200-0011

Rack for holding 25x 8 vials, 4.0 ml

81-200-0002

Rack (cooled) for holding 25x 8 vials, 4.0 ml

81-200-0012

Dilution option, incl. 3-part container

81-207-0020

54
ERWEKA UV-VIS In- or Online System
(analysis only)

1. Sample Transfer Pump 2. UV-VIS Spectrophotometers

1.1. Sample Transfer Pump IPC 8 Shimadzu 1800
(Peristaltic Pump) Double beam in-
cluding 8 position
cell changer,
ready for Online
Systems

230V/50 Hz 72-206-2031
230V/60Hz 72-206-2032
115V/60Hz 72-206-2033
With the standard ERWEKA 8-channel Peristal- 127V/60Hz 72-206-2034
tic Pump (IPC 8) the sample is taken from the
test vessel and injected to the flow-through cells Analytic Jena Specord 205
of the spectrophotometer. After analysis the double beam including 8 position cell changer,
sample is transferred back to the test vessel. ready for Online Systems
Pump tubings are made of Verderprene (simi- 230V/50Hz 72-204-0001
lar to Teflon) to prevent the absorption previ- 230V/60Hz 72-204-0002
ously associated with peristaltic pumps and 115V/60Hz 72-204-0003
PVC tubing. 127V/60Hz 72-204-0004
Via the serial RS 232 interface the pump is
controlled from the external PC. ERWEKA SPM
Double beam
8-channel Peristaltic Pump including 8 posi-
RS 232 serial interface for external control tion cell
Touch sensitive keys and LC display changer, ready
Verderprene tubing for elimination of ab- for Online Sys-
sorption of active ingredients by PVC tub- tems including
ing tubing.

1.2. Agilent Sample Transfer 230V/50Hz 72-203-0001

Pump 230V/60Hz 72-203-0002
115V/60Hz 72-203-0003
When ordering the Online Dissolution Package 127V/60Hz 72-203-0004
with Agilent 8453 Diode Array, the Systems
comes with Agilent 8-channel Peristaltic Pump.
System Control via Agilent Software instead of
ERWEKA [Link] (see 3.2).

55
 Perkin Elmer 3. System Control
Lambda 25
Double beam in-
cluding 8 position
3.1. [Link] Software
cell changer, ready
for Online System Windows based ERWEKA
including [Link] software
tubing and Perkin Elmer WinLab 2 Software [Link]. Windows based
Package CFR 21/11 compliant
ERWEKA Dissolution Sys-
230V/50Hz 72-203-2001 tem Software [Link]
230V/60Hz 72-203-2002
115V/60Hz 72-203-2003 Recommended PC configuration:
127V/60Hz 72-203-2004 - Processor: Pentium IV 1.2 GHz
- Memory: 256 MB, HDD free space: 300 MB
Perkin Elmer - Operating system: MS Windows 7 or MS
Lambda 35 Windows XP Professional
Double beam in- - Screen resolution: 1024x768 (minimal),
cluding 8 position 1280x1024 (recommended)
cell changer, ready
for Online System 3.2. Driver for Agilent 8453
including
tubing and WinLab 5 Perkin Elmer Software Agilent Chem Station and Agilent Dissolution
Package. Software package as well as ERWEKA driver to
connect and control Dissolution Testers of the
230V/50Hz 72-203-2011 ERWEKA DT 700/800 Series.
230V/60Hz 72-203-2012
115V/60Hz 72-203-2013
127V/60Hz 72-203-2014
4. System Tubing

Agilent 8453, System Tubing, complete with tubing and con-

including 8 position nectors, Teflon 3.0 mm o.d., configured as
cell changer, ready for Inline-System (return to vessel after analysis).
Online Systems in-
cluding tubing 5. System Pre-Configuration
Control and Pre-Configuration of the complete
system at the ERWEKA laboratory. Control of
function and numbering of all tubes and inter-
230V/50Hz 72-203-5001 face cables for easy connection at the custom-
230V/60Hz 72-203-5002 ers site.
115V/60Hz 72-203-5003
127V/60Hz 72-203-5004 6. Computer
Brand name computer in minitower housing
- CPU Intel Pentium 4 min. 2.8 GHz
- Hard disk min. 40 GB
- Main memory min. 512 MB
- 3x serial interface
- 6 USB 2.0 interfaces
- 16xDVD-ROM device
Operating system Windows XP, keyboard,
scroll mouse, 17 flat-screen TFT monitor.

Customer specified computer, printer and moni-

tor available on special request!!!

56
Prices include:
1. ERWEKA Peristaltic Pump IPC 8 or
2. Cuvettes for UV-VIS
Agilent Peristaltic Pump
2. UV-VIS Spectrophotometer incl. Cell- With Teflon tubing (0.8 mm o.d.) and screw-
Changer, fittings. For 8-position cell changers
3. ERWEKA Windows based 21 CFR 11
com- pliant Software, Type [Link],
with Interface Boxes for control of UV-
VIS of ERWEKA, Perkin Elmer, Shima-
dzu, Analytic Jena and Agilent
or
Agilent Chem Station and Driver for
ERWEKA Dissolution Bath
4. Computer, TFT monitor, colour printer
5. Teflon Tubing/Connector Kit and Pre-
Configuration
1x Path Length 10 mm 80-203-0010
!!! Excluding IQ document/s, Dissolution 1x Path Length 5 mm 80-203-0005
Tester, Sample Withdraw System and Cu- 1x Path Length 2 mm 80-203-0002
vettes !!! 1x Path Length 1 mm 80-203-0001

Options 3. Cuvettes for UV-VIS (other

than standard)
1. Sample Transfer Pump, 8 off Path Length 10 mm 80-203-2110
PVP 720/820 8 off Path Length 5 mm 80-203-2105
8 off Path Length 2 mm 80-203-2102
8 off Path Length 1 mm 80-203-2101

2. IQ/OQ/PVT documents for

UV-VIS
Perkin Elmer 75-203-2999
Shimadzu 75-203-3999
Cecil 75-203-4999
Agilent 75-203-5999

7-channel (optional 8-channel) high pressure, 5. Tubing (other than 3.0 mm;
valve free Teflon/Ceramics Piston Pump for all
Dissolutions Systems which require membrane only with IPC 8)
filtration below 1 m (dependant on the product
this pump allows filtration down to 0.22m) Additional price for other tubing than standard
(Teflon 3.0 mm o.d.).
High dosage accuracy ( 0.5 ml) and fast oper-
ation (sampling intervals from 2 minutes) in Verderprene 60-203-0002
combination with FRL 724/824 Fraction Collec- PEEK 60-203-0003
tors.

PVP 720, 7-channel piston pump

11-312-1201

PVP 820, 8-channel piston pump

11-312-1211

57
ERWEKA UV-VIS Dual Online Systems
(analysis for 2 independent Dissolution Testers)

1. 2 off Sample Transfer Pump, 2. UV-VIS Spectrophotometers

IPC 8 (Peristaltic Pump)
ERWEKA SPM
double beam in-
cluding 16 position
cell changer and
tubing, ready for
Online Systems.

3. System Control
ERWEKA Dissolution Software type
With the standard ERWEKA 8-channel Peristal- [Link]
tic Pump (IPC 8) the sample is taken from the The ERWEKA [Link] Software is able to run
test vessel and injected to the flow-through cells under Windows XP and Windows 7. For Dual
of the spectralphotometer. After analysis the Online System (Dissolution Testers, Sample
sample is transferred back to the test vessel. Transfer Pumps and UV-VIS Photometer Perkin
Elmer).
Pump tubings are made of Verderprene (simi-
lar to Teflon) to prevent the absorption previ-
ously associated with peristaltic pumps and 4. System Tubing
PVC tubing.
Via the serial RS 232 interface the pump is System Tubing, complete with tubing and con-
controlled from the external PC. nectors, Teflon 3.0 mm o.d.

8-channel Peristaltic Pump

RS 232 serial interface for external control
Touch sensitive keys and LC display
Verderprene tubing for elimination of ab-
sorption of active ingredients by PVC tub-
ing

58
5. System Pre-Configuration Options
Control and pre-configuration of the complete 1. Cuvettes for UV-VIS (other
system at the ERWEKA laboratory. Control of
function and numbering of all tubes and inter- than standard)
face cables for easy connection at the custom- 8 off Path Length 10 mm 80-203-2110
ers site. 8 off Path Length 5 mm 80-203-2105
8 off Path Length 2 mm 80-203-2102
8 off Path Length 1 mm 80-203-2101
6. Computer
Brand name computer in minitower housing 2. IQ/OQ/PVT Documents for
CPU Intel Pentium 4 min. 2.8 GHz
Hard disk min. 40 GB UV-VIS
Main memory min. 512 MB IQ/OQ/PVT document for Dual Online Sys-
1 serial interface tem 75-205-x999
6 USB 2.0 interfaces
16x DVD-ROM device
Operating system Windows XP, keyboard,
scroll mouse, 17 flat-screen TFT monitor.
3. Tubing (other than standard)
Tubing, Verderprene 60-205-0002
Customer specified computer, printer and moni-
tor available on special request!!! PEEK 60-205-0003

Prices includes:
1. 2 off Peristaltic Pump, IPC 8
2. UV-VIS Spectrophotometer incl. Cell-
4. Sample Transfer Pump
Changer and 16x 10 mm Cuvettes ERWEKA Dual Online Dissolution System
3. ERWEKA Windows based [Link] with can also be operated with two high-
intelligent Interface Box precision, high power, absorption-free
4. Computer, monitor and printer ERWEKA Piston Pumps (PVP 720/820) in-
5. Teflon Tubing/Connector Kit and Pre- stead of the 2 standard Peristaltic Pumps.
Configuration Additional price

!!! Excluding IQ document/s and Dissolution 2x PVP 720 11-312-1201

Testers with Sample Withdraw System !!! 2x PVP 820 11-312-1211

230V/50Hz 76-205-2011
230V/60Hz 76-205-2012
115V/60Hz 76-205-2013
127V/60Hz 76-205-2014

59
ERWEKA UV-VIS Off-/Online System
(storage, media replacement, dilution and UV-VIS analysis)

1. Sample Transfer Pump, 2. Autosampler, FRL 820

SP 825/25 (Syringe Pump)

The ERWEKA 8-channel Syringe Pump, Type

SP 825/25 with 25 ml Syringes is the ideal Me- The FRL 820 was designed to meet all users
dia Transfer Pump for all kind of Dissolution requirements such as storage of the samples,
Systems. It offers very accurate volume flow, dilution of the stored samples and when con-
elimination of absorption (glass/Teflon) and nected to a UV-VIS Spectrophotometer, trans-
high flexibility due to an electric 4-way valve at fer of the diluted or undiluted sample with the
the in-/outlet of each syringe. This unique de- need of only one ERWEKA 8-channel Syringe
sign allows performing all needed steps for the Pump, Type SP 825/25.
Dissolution Test, even dilution, media replace- In combination with an ERWEKA Dissolution
ment and transfer from the Fraction Collector to Tester, the ERWEKA Dissolution Software
an UV-VIS system with only one pump! The SP package and the before mentioned Syringe
825/25 is equipped with a RS 232 interface for Pump, the system offers storage in either glass
control by the ERWEKA [Link] software. tubes (25x 8 of 10 or 17x 8 of 25 ml volume) or
sealed/ unsealed HPLC vials (25x 8 of 1.5 or
8-channel Syringe Pump 4.0 ml volume).
8 electric 4-way valves, absorption free Due to the 8-channel ERWEKA Syringe Pump,
Hamilton syringes 25 ml the samples are dosed with a high accuracy of
Accuracy of volume 0,2 ml (25 ml sy- volume.
ringes) When the sample is taken, the withdrawn media
RS 232 serial interface volume may be replaced with fresh media from
Teflon tubing a media replacement container, integrated in
the FRL 820. Two 1-channel Peristaltic Pumps
refills the media replacement container auto-
matically after the media replacement process.
The stored sample may be diluted with dilution
media in a ratio of max. 1:10 from an integrated
dilution media container (to be automatically
refilled from an external media

60
container by a Peristaltic Pump integrated in the 3. UV-VIS Spectrophotometers
FRL 820).
In combination with the ERWEKA Windows
based [Link] software and an UV-VIS Spec- ERWEKA SPM
trophotometer with Cell-Changer, the withdrawn double beam in-
sample can be either transferred directly from cluding position
the Dissolution Tester to the UV-VIS, be stored cell changer.
in the tubes of the FRL 820 and later analysed Ready for Online
or stored in tubes, automatically diluted and Systems includ-
transferred to the UV-VIS for analyses using ing tubing and
only one pump! Microsoft Windows-based software [Link]
by ERWEKA.
Precision dosing by the ERWEKA 8-
channel Syringe Pump, SP 825/25 230V/50Hz 71-203-2111
Stores up to 8 samples for up to 25 sam- 230V/60Hz 71-203-2112
pling cycles 115V/60Hz 71-203-2113
Samples into tubes (10 or 25 ml) 127V/60Hz 71-203-2114
Samples into sealed or unsealed HPLC
Vials (1.5 or 4.0 ml max. volume) 4. System Control
Standard HPLC Vial membrane piercing
Media replacement to stay within the [Link]
USP/EP specified media volume tolerance The ERWEKA [Link] software is able to run
Integrated container for replacement me- under Windows NT and Windows XP.
dia, incl. two 1-channel Peristaltic Pumps For Off-/Online System (Dissolution Tester,
to refill the integrated container from an ex- Sample Transfer Pump, Fraction Collector and
ternal one after each replacement process UV-VIS Photometer Perkin Elmer and Shima-
Automated dilution system (ratio up to dzu, ERWEKA, Analytic Jena and Agilent.
1:10); accuracy to 2 ml
Integrated container for dilution media, incl.
1-channel Peristaltic Pump to refill the in-
5. System Tubing
tegrated container from an external one af-
ter each dilution process System tubing, complete with tubing and con-
Automated transfer of the diluted/undiluted nectors, Teflon 3.0 mm o.d.
sample to an UV-VIS Spectrophotometer
with Cell-Changer, using the ERWEKA 6. System Pre-Configuration
Windows based [Link] software
Control and pre-configuration of the complete
system at the ERWEKA laboratory. Control of
function and numbering of all tubes and inter-
face cables for easy connection at the custom-
ers site.

61
7. Computer 1.2 Racks for Autosampler

Brand name computer in minitower housing

CPU Intel Pentium 4 min. 2.8 GHz
Hard disk min. 40 GB
Main memory min. 512 MB
1 serial interface
6 USB 2.0 interfaces
Rack for 25x 8, for HPLC vials of 1.5 ml
16x DVD-ROM device
volume 80-300-0001
Operating system Windows XP, keyboard,
Rack for 25x 8, for HPLC vials of 4.0 ml
scroll mouse, 17 flat-screen TFT monitor.
volume 80-300-0002
Customer specified computer, printer and moni-
Rack for 25x 8, with glass tubes of 10 ml
tor available on special request!!!Prices in-
volume 80-300-0003
clude:
Rack for 17x 8, with glass tubes of 25 ml
1. ERWEKA Syringe Pump SP 825/25
volume 80-300-0004
2. Autosampler FRL 820
3. UV-VIS Spectrophotometer incl. Cell-
Changer 1.3. Probes for Autosampler
4. ERWEKA Windows based [Link] (FRL x20)
software with intelligent Interface Box
5. Computer, monitor and printer Titanium probes instead of st. steel probes
6. Teflon Tubing/Connector Kit and Pre- 70-20x-x1xx
Configuration
2. Cuvettes for UV-VIS
!!! Excluding Racks, IQ/OQ/PVT document/s
and Dissolution Tester with Automatic With Teflon tubing (0.8 mm o.d.) and screw-
Sampling Station !!! fittings
1x Path Length 10 mm 80-203-0010
230V/50Hz 76-206-2001 1x Path Length 5 mm 80-203-0005
230V/60Hz 76-206-2002 1x Path Length 2 mm 80-203-0002
115V/60Hz 76-206-2003 1x Path Length 1 mm 80-203-0001
127V/60Hz 76-206-2004

Options 3. Cuvettes for UV-VIS (other

than standard)
1.1 Valve-Box in the return channel
8 off Path Length 10 mm 80-203-2110
A valve box with 8x 3-way valves allows 8 off Path Length 5 mm 80-203-2105
analysing either samples withdrawn di- 8 off Path Length 2 mm 80-203-2102
rectly from the Dissolution vessel and 8 off Path Length 1 mm 80-203-2101
automatically diluted samples which are
transferred from the Fraction Collector to
the connected UV-VIS.
Media coming directly from the vessel after
4. IQ/OQ/PVT Documents for
analysis is transferred back to the vessel; UV-VIS
diluted samples coming from Fraction Col-
lector are directed to waste. Perkin Elmer 75-203-2999
Shimadzu 75-203-3999
230V/50Hz 80-206-0001 Cecil 75-203-4999
230V/60Hz 80-206-0002
115V/60Hz 80-206-0003
127V/60Hz 80-206-0004

62
ERWEKA Half-Automated UV-VIS- and
HPLC-Online Dissolution System HADs

The highest degree of automation and flexibility UV-VIS Online Connection

is offered by the new half-automated Dissolu- In addition to the HPLC connection the
tion System. The HADs bases on the full vali- ERWEKA HADs offers the possibility to include
dated software of the ERWEKA RoboDis and a UV-VIS Spectrophotometer (ERWEKA, Per-
therefore is prepared for UV-VIS-, HPLC analy- kin Elmer, Shimadzu, Analytic Jena, Agilent)
sis, fraction collection as well a combination of into the close-loop sample withdraw system, so
all. Thats the breakthrough for method devel- i.e. between the sample transfer pump and the
opment as well as for highest flexibility. PEEK flow-through vial block or the PEEK flow-
through vial block and the return to the dissolu-
The HADs uses an innovative flow-through tion tester.
system of sealed PEEK-vials. The sample is Therefore the ERWEKA HADs can be used as
withdrawn from the dissolution vessel through sample collection device (max. 324 samples;
tip filters from 1 m porosity by a peristaltic incl. sample tempering), a HPLC Online System
pump (in case of filtration from 0.22 m porosity in combination with virtually any brand of HPLC
instead the membrane filter changer AFC 825 device and an Online UV-VIS system (incl. vir-
(see page 39) or double filtration station in tual dilution by various path length with opti-
combination with the piston pump PVP 820 can mized flow-through cuvettes).
be used) to the PEEK block of sealed flow-
through vials integrated in the auto sampler. Capacity
The ERWEKA HADs allows two Dissolution
Operation Tester via two individual sample transfer pumps
A x/y/z driven arm with an embedded syringe to one auto sampler with two embedded PEEK
picks up the samples from the flow-through flow-through vial blocks (no cross contamina-
vials and store them into HPLC vials (max. 324 tion). Either none, one or both of the Dissolution
sealed vials; optionally electronically tempered testers, in addition to the HPLC Online system,
from 4 to 70). A time managing program opti- can be fitted with a UV-VIS Spectrophotometer
mizes and calculates when a sample can be inside the closed-loop sampling system.
transferred from the HPLC-Vials to the Rheo-
dyne valve for HPLC analysis. A direct online Software

injection without buffering the samples is also Based on the ERWEKA standard [Link]
possible. software, the system enables the im-/export to
The auto sampler offers such features as mul- other IT-systems for e. g. LIMS or chromato-
tiple standard racks for HPLC device calibra- graphy data systems. Also the automatic re-
tion, needle wash station, replacement of the cording of sampling times, temperature and
withdrawn sample volume by fresh media. rotation speed in each vessel brings facilitation.
Every deviation is documented automatically.
HPLC Online connection
Connection to equipment of all manufacturers Video monitoring
for e. g. Shimadzu, Agilent and Waters as well An automated system runs without user obser-
as the possibility of a connection to different vation. What to do when the results of the dis-
chromatograph systems like Empower (Waters) solution test arent as expected, too low or too
or Cerity (Agilent). high? Nobody had been there during the test,
nobody knows if this has been caused by the

63
sample itself or by system errors such as com- Titanium Sampling- and Replacement
ing, sticking etc. So what to do with the incor- tubes (instead of [Link]), corrosion-free
rect results? To through them and hide them 80-090-0200
from the authorities? To eliminate that problem
completely the ERWEKA HADs is available with Cleaning Reservoir for sampling station;
video monitoring of six dissolution vessels of with 3 compartments to avoid any cross-
one or both connected dissolution testers. The contamination. 80-089-0000
video monitoring allows recording of each test-
run in combination with real-time overlapping Electronic (waterless) calibration System
dissolution profile to identify disturbances such for calibration of PT 100 temperature sen-
as coning etc. and to get the visual impression sors, recommended with 10-092-0001
of 24 hours in 2 minutes. The video monitoring
is a very powerful tool for method development
as well for troubleshooting. 2. Options
230V/50Hz 72-210-0001 7 test-stations (instead 6); Position 7 with
230V/60Hz 72-210-0002 drive shaft; Additional price 14-x7x-7xxx
115V/60Hz 72-210-0003
127V/60Hz 71-210-0004 External electronic temperature sensor PT
100 for display of water bath - or media tem-
perature. Extended instrument menu for
1. Dissolution Tester/s one-point calibration routine as well as cali-
up to two Dissolution Testers can be con- bration hard-copy documentation.
nected to one HADs 84-070-0100

Automated Tablet Drop Magazine (instead

Dissolution Tester, Type DT 726/LH-1000
manual operation of standard tablet drop
The 8 position - 6 test-stations DT 726 is the
magazine). With temperature check before
ideal NG Dissolution Tester for software
drop. 84-070-0010
controlled Dissolution System. While con-
trols are performed via the PC the unit itself Illumination of the water bath by integrated
shows its run conditions at individual bright LEDs 84-090-0112
LE displays. The DT 720 series includes
such features as MagniShaft "tool-free" stir- Vessel Centering Ring for centering and
rer exchange system, fully corrosion-free holding ERWEKA Vessel 84-060-3000
construction (alloy; fibreglass etc.), one-
piece mould water bath with powerful exter- USP compliant Vessel, Polycarbonate
nal flow-through heater, fast moving column 80-000-1001
for the drive heat etc. "Low-Head" configura-
tion ("High-Head" on special request).(for USP compliant Vessel, glass, standard
Dual system 2x DT 726/LH-1000 have to be 80-000-1002
selected) 14-070-6001
USP compliant Vessel, glass, numbered
Automated Sample Withdraw System with certificate of compliance
Driven bar with attached sampling- and re- 85-000-1002
placement tubes ([Link]) for sample-
withdraw and -replacement. Microprocessor USP compliant Vessel, UV resistant brown
controlled to withdraw at the USP/EP speci- glass 80-000-1004
fied sampling height (midway) for each com-
bination of media volume and stirrer type. USP compliant Vessel, UV resistant glass,
14-x7x-x4xx numbered with certificate of compliance
85-000-1004
Automated Sample Withdraw System
Same as above - but with 8 additional elec- Full-Teflon Paddle and Shafts (one piece
tronic temperature sensors for display and mould); numbered
documentation of the media temperature in MagniShaft 84-000-7001
each Vessel. 14-x7x-x9xx UniShaft 84-010-7001
St. Steel 84-010-7002

64
 Full-Teflon Paddle and Shaft (one piece 4. Filtration
mould); numbered, certificate of compliance
The kind of filtration required depends on the
MagniShaft 89-000-7001 product to test
UniShaft 89-010-7001
Tip Filtration by Poroplast filters (from 1 m)
Full-Teflon Basket holder and Shafts; num- attached to the sampling tube of the Sam-
bered pling System comes as standard
UniShaft 84-010-6011
MagniShaft 89-000-6001 Double Filtration System combination of a tip
St. Steel 84-010-6012 filter (see above) and one membrane filter
(typically from 0.45 m) integrated in the
Full-Teflon Basket holder and Shaft; num- flow of the withdrawn sample. For filtration
bered with certificate of compliance below 1.0 m Media Transfer Pump PVP
UniShaft 89-010-6001 820 is recommended! 80-070-0955
MagniShaft 89-000-6001
Automatic Filter Changer, Type AFC 825
Basket, mesh 40 90-000-6040 Unit for exchange of the membrane filters af-
ter each sampling interval (selectable) with
Basket, mesh 40, numbered with certificate storage capacity for 8x 25 membrane filters.
of compliance 95-000-6040 Media replacement only available in combi-
nation with filter exchange.
Basket, mesh 20 90-000-6020 12-085-0825

Basket, mesh 20, numbered with certificate

of compliance 95-000-6020 5. Sample Transfer Pump
Basket, mesh 10 90-000-6010 Sample Transfer Pump, Peristaltic 8-channel
Ismatec Peristaltic Pump incl. Verderprene
tubing. Usage depends (usually not below
Other methods (USP 5, 6 etc.) and Vessel for 1m) on filter and product to be used.
other media volume on request 11-202-5000

Sample Transfer Pump, Piston (high pres-

3. Video Monitoring/Recording sure) 8-channel ERWEKA valve-free Tef-
lon/Ceramics Piston Pump. Dependant on
Video Monitoring/Recording of Dissolution the product this pump allows filtration down
Tester 1 (6 stations). Recording of the disso- to 0.22m due to the high pressure created.
lution process and time laps view with real- High dosage accuracy. 10-312-1201
time dissolution curve overlay (only in com-
bination with UV-VIS Online analysis)
72-210-1xxx 6. Half-automated HPLC- and
Video Monitoring/Recording of Dissolution UV-VIS Online, HADs
Tester 2 (6 stations).Recording of the disso-
lution process and time laps view with real- HADs Base Module
time dissolution curve overlay (only in com- HADs for HPLC Online analysis, incl. block
bination with UV-VIS Online analysis) of sealed PEEK flow-through vials, rack for
72-210-2xxx up to 5 standards for calibration and system
suitability, needle/syringe wash-station, me-
Upgrade Software for Video Monitor- dia replacement, sample handling system, 1-
ing/Recording tool (in case both testers are channel syringe pump, 6-port HPLC valve
equipped with Video Monitoring/Recording and system tubing/pre configuration; for
the upgrade software is only required once). connection of 1 Dissolution Tester; for con-
50-050-0000 nection of 1 HPLC system with software
(Agilent, Waters, Shimadzu, Merck/Hitachi
etc.) Price excluding sample transfer pump,
sample collection rack, software and HPLC-
and UV-VIS unit! 72-210-0001-4

65
 Dual System Upgrade dated HADs Dissolution software for Online
Possibility of connecting a 2nd Dissolution UV-VIS analysis incl. protocols. Excluding
Tester to HADs; incl. 2nd block of sealed flow-through cuvettes! 72-21x-xx2x
PEEK flow-through vials, system tub-
ing/configuration and software upgrade.2nd Flow-Through optimized Cuvette, 20 mm
Dissolution Tester and Sample Transfer 80-203-0020
Pump required! 72-211-xxxx
Flow-Through optimized Cuvette, 10 mm
TTL Interface box for TTL-controlled HPLC 80-203-0010
connections, e.g. Agilent 81-010-0001
Flow-Through optimized Cuvette, 5 mm
Cable for manual injection into Rheodyne 80-203-0005
Valve 81-010-0002
Flow-Through optimized Cuvette, 2 mm
Rack (103+5) 80-203-0002
Offline sample collection into sealed HPLC
vials (103 for collection + 5 for standards), Flow-Through optimized Cuvette, 1 mm
for automatic transfer to the 6-port HPLC 80-203-0001
valve 72-21x-x1xx

Rack (319+5) PC
Offline sample collection into sealed HPLC
vials (319 for collection + 5 for standards), PC supplied by the customer according to
for automatic transfer to the 6-port HPLC ERWEKA specification; delivered to
valve 72-21x-x2xx ERWEKA; installation of [Link]
62-210-1000
Rack (93+5), cooled
Offline sample collection (cooled; 4C - PC standard PC for [Link] software
70C) into sealed HPLC vials (93 for collec- 52-210-1000
tion + 5 for standards), for automatic transfer
to the 6-port HPLC valve 72-21x-x3xx PC High-Power PC for [Link] with Video
Monitoring
Rack (319+5), cooled 80-430-5001
Offline sample collection (cooled; 4C -
70C) into sealed HPLC vials (319 for collec-
tion + 5 for standards), for automatic transfer
to the 6-port HPLC valve 72-21x-x4xx Installation Services
Software Package [Link] Installation and IQ/OQ/PVT on-site exclud-
Software for control of Dissolution Tester/s, ing travel expenses 62-210-0000
Automatic Filter Changer/s, Sample Transfer
Pump/s and HADs 14-950-3005 Travel expenses for on-site installation
62-210-0001
UV-VIS integration Module
Integration of UV-VIS Spectrophotometer in- IQ/OQ/PVT documents in English language
to the flow-line of the Dissolution Tester; incl. 62-210-9999
UV-VIS Spectrophotometer (ERWEKA SPM,
Perkin Elmer Lambda 25 or Shimadzu 1800) IQ/OQ/PVT documents in other language
with 8 position cell changer, Dissolution Kit, than English 62-210-8999
additional tubing/connectors and upgraded
validated HADs Dissolution software for On- First PV (per Dissolution Tester) excluding
line UV-VIS analysis incl. protocols. Exclud- travel expenses (when has to be travelled
ing flow-through cuvettes! 72-21x-xx10 separately) 62-210-0002

UV-VIS integration Module, Agilent First PV, HADs excluding travel expenses
Integration of UV-VIS Spectrophotometer in- (when has to be travelled separately)
to the flow-line of the Dissolution Tester; incl. 62-210-0003
UV-VIS DAD Photometer (Agilent 8254) with
8 position cell changer, Dissolution Kit, addi- Travel expenses for First PV when has to be
tional tubing/connectors and upgraded vali- travelled separately) 62-210-0004

66
ERWEKA RoboDis

With its RoboDis ERWEKA sets the Cleaning

benchmark in the high-end of automated On completion of the test-run the vessels are
dissolution testing. emptied by sucking (no valves in the vessel),
The system has been developed in close co- remaining tablet debris can be dissolved by
operation with Bayer Healthcare and there- cleaning solution or sucked out by a special
fore reflects state-of-the-art operational sucking arm and the complete system is
know-how acquired in over 15 years of rinsed/sprayed by either water, hot water or a
process optimization and automation in combination of cleaning solution and water.
method development and quality control A valve allows splitting the used media into
laboratories. The ERWEKA RoboDis is a either standard waste water and contaminated
fully automatic Dissolution Tester capable waste water.
of carrying out up to 20 USP Apparatus 1 or
2 tests. Methods
The RoboDis is designed for the fully auto-
2-in-1 mated performance of up to 20 dissolution tests
The RoboDis includes two 8-station Dissolution according to the latest USP/[Link]./JP
Testers which are operated by an industrial 3- requirements. It supports the following methods
axis Robot. and processes:
The use of 2 Dissolution Testers increases the - Performance of tests with USP Apparatus 1
throughput over other automated Dissolution and 2
Systems. - Alternate use of method from Apparatus 1 to
2 and vice versa
Vessel Filling - USP compliant Basket start routine
As standard the RoboDis offers volumetric - Use of Japan Sinkers
filling of the vessels. The ERWEKA RoboDis is a fully automatic
The actual filling level of each vessel is con- Dissolution Tester capable of carrying out up to
trolled and documented by control weighing. 20 USP Apparatus 2 and 16 USP Apparatus 1
Optionally a medium selector is available which tests.
offers using up to 6 kinds of media.
Filtration
Filtration can be performed by either Tip-Filters
dependant on the analysis system used.

67
Analytics 1. Base Unit
The RoboDis offers maximum flexibility con-
cerning the analytical method applied as well as RoboDis, Base Module with 7 test-station
full visual supervision of the dissolution dissolution tester for USP 2 Paddle method.
process: Media feeding from one external container,
- UV-VIS in-vitro measuring based on fiber volumetric media dosing with weight control,
optics (no Multiplexer used) sample insert, media disposal and ves-
- Online measuring based on UV-VIS and/or sel/stirrer cleaning. Including digital robot,
HPLC analysis heated water bath with holding plate for 7
- Measuring of calibration and control stan- vessels, PH-Monitoring, PTFE sample sto-
dards in case of online-operations rage magazine (10x 6), connection for air
supply, connection of cleaning- and waste
System Control water by magnetic valves.
- 21 CFR Part 11 compliant Windows based 40-070-0000
software package
- SQL Database PC supplied by the customer according to
- Online-control of rpm and temperature in ERWEKA specification. Installation on-site
each individual vessel and in the bath 5002
Video Controlling Standard PC for [Link] software
Additionally the RoboDis offers Video analysis 5000
of dissolution process in time-lapse mode with
overlapping real-time dissolution curve to show High-Power PC for [Link] only for Video
effects of i.e. coning etc.. Monitoring 5001
Compliance Software Package [Link]
The RoboDis is compliant with all other rele- Software for control of RoboDis Base Mod-
vant regulatory standards in the pharmaceutical ule, including control of media switch and
industry such as: media degassing container 6000
- 21 CFR Part 11
- GAMP (current edition)
- CGMP (FDA) 2. Options
- GMP Guidelines of the EU
- EMC directive according to EN 61010 USP compliant Vessel, glass, standard
- Guidelines of US Pharmaceutical Manufac- 2000
turer is Association (PMA)
USP compliant Vessel, glass, numbered
with certificate of compliance 2001

USP compliant Vessel, UV resistant brown

glass 2002

USP compliant Vessel, UV resistant brown

glass, numbered with certificate of com-
pliance 2003

USP compliant Shaft with Paddle, [Link]

2010

USP compliant Shaft with Paddle, [Link];

numbered with certificate of compliance
2011

68
3. Extensions
Media Degassing and pre-heating auto- Video Monitoring/Recording of Dissolution
mated integrated container for pre-heating Tester 2 (6 stations). Recording of the disso-
and automated degassing by vacuum. lution process and time laps view with real-
3000 time dissolution curve overlay (only in com-
bination with Fiber-Optics/UV-VIS Online
Media Switch, automated Valve for connec- analysis) 4101
tion of up to 6 pre-mixed media
3001 Upgrade Software for Video Monitor-
ing/Recording tool (in case both testers are
Media Container made from PVC; 120 l. equipped with Video Monitoring/Recording
volume; mobile on wheels; with outlet; op- the upgrade software is only required once).
tionally color coated 3100 6002

Media Container made from PVC; 120 l.

volume; mobile on wheels; with outlet; with 4. Basket Handling Module
integrated magnetic stirrer; optionally color
coated 3101 Basket Exchange Module for fitting of pre-
loaded USP compliant Baskets (mesh
2nd Dissolution Tester integrated second 8 10/20/40 available) as well as Basket re-
test station Dissolution Tester for USP 2 moval on completion of the test-run. Exclud-
Paddle method, integrated and handled by ing Baskets and Rack for storage of the pre-
the RoboDis robot for fully automated opera- loaded Baskets 9000
tion, including media dosing/filling, sample
insert, media disposal and vessel/stirrer Basket storage magazine for max. 8x 6
cleaning. Baskets, right side. For up to 15 automated
Water bath with a 2nd flow-through heating test runs (10x Paddle- and 8x Basket me-
system and holding plate for 8 vessels is in- thod) 9005
cluded. 1507
Basket storage magazine (instead standard
Upgrade Software for [Link] handling two sample storage magazine, left) for max. 8x 6
Dissolution Testers 6004 Baskets, left side. For up to 16 automated
Basket test runs (in combination with Item-
2nd sample storage magazine, for Paddle No. 9005) 9004
use PTFE magazine (10x 6 samples), right
side. For up to 20 automated test runs Basket, mesh 40; incl. holder 9040
3600
Basket, mesh 40, numbered with certificate
Japanese sinker handling collection tool for of compliance; incl. holder 9045
Japanese sinkers, tool-stand and collection
container incl. sensor for check of removal Basket, mesh 20; incl. holder 9020
4000
Basket, mesh 20, numbered with certificate
Upgrade Software for handling Japanese of compliance; incl. holder 9025
Sinker tool 6001
Basket, mesh 10; incl. holder 9010
Video Monitoring/Recording of Dissolution
Tester 1 (6 stations). Recording of the disso- Software Module for Basket Module integra-
lution process and time laps view with real- tion into [Link] 6009
time dissolution curve overlay (only in com-
bination with Fibre-Optics/UV-VIS Online
analysis) 4100

69
Analytical Modules
Fibre Optics UV-VIS Online
Fiber Optics UV-VIS System Module in-situ
measurement of the absorption (exchan-
geable tips for various path-length) in ei-
ther one or two dissolution testers, incl. ca-
libration and verification routine. In combi-
nation with the Video Recording/Monitoring
option this Module allows to record a time-
laps movie with real time dissolution result
overlay. Comprising of: ZEISS DAD Pho-
tometer, Type MCS 651 UV, complete with
light conductor (2x 3m) with Optrode, Type
Hellman QX for below Tips (optimized for
Dissolution use), Cover (stand) for Photo-
meter, configuration and fiber optic cabling,
Container for standard solutions (10), Tool
hand for operation of fiber optics UV-VIS
Optrode, incl. cleaning/drying station and
PT 100 temperature sensor. 7000

Software Module for fiber optics UV-VIS

integration into [Link] 6003

20 mm path length tips for attaching to

standard Optrode 7020

10 mm path length tips for attaching to

standard Optrode 7010

5 mm path length tips for attaching to

standard Optrode 7005

2 mm path length tips for attaching to

standard Optrode 7002

1 mm path length tips for attaching to

standard Optrode 7001

70
Dissolution Accessories
Glassware for Dissolution
Polycarbonate, 1000 ml 85-000-2004
UV-resistant USP round-bottomed vessel with
80-000-1001 stand, made of glass, numbered with certificate
USP round-bottomed ves- of compliance, 2000 ml
sel, made of plastics, 1000
ml As of 2010 1000 and 2000 ml vessels will be
delivered with integrated stand. The stand is

made of Polyoxymethylene-Delrin and can be
removed - if necessary.

Glass, 4000 ml
Glass, 1000 ml
80-000-4002
80-000-1002 USP round-bottomed vessel, made of glass,
USP round-bottomed ves- 4000 ml
sel with stand, made of
glass, numbered, 1000 ml 85-000-4002
USP round-bottomed vessel, made of glass
85-000-1002 with certificate of compliance, 4000 ml
USP round-bottomed
vessel with stand, made
of glass, numbered with Glass, 250 ml
certificate of compliance,
1000 ml 80-000-0202
Round-bottomed vessel,
made of glass, 250 ml
80-000-1004
UV-resistant USP round- 80-000-0204
bottomed vessel with Round-bottomed vessel,
stand, made of glass, glass, 250 ml
1000 ml

85-000-1004 Conversion Kit for 250 ml Vessels

UV-resistant USP round-
bottomed vessel with 84-000-9200
stand, made of glass, Conversion Kit for
numbered with certificate holding Mini-Vessel
of compliance, 1000 ml (1) in standard Vessel
opening; comprising
of adapter ring and
Glass, 2000 ml cover (without Mini-
Vessel); for High-
80-000-2002 Head use
USP round-bottomed vessel with stand, made
of glass, numbered, 2000 ml Conversion Kit for conversion from
1000 ml to 250 ml with Mini Paddle
85-000-2002
USP round-bottomed vessel with stand, made 81-000-7303
of glass, numbered with certificate of compli- Conversion Kit LH
ance, 2000 ml
81-000-7213
80-000-2004 Conversion Kit HH
UV-resistant USP round-bottomed vessel with
stand, made of glass, 2000 ml

71
Stirring Elements
USP apparatus 1 (Basket)
1. MagniShaft
Basket holders and shafts
84-000-6011 Basket holder with upper shaft 89-030-6001 Basket holder with upper shaft
(integrated in drive head) and (integrated in drive head) and
lower shaft (Teflon) for 1000 ml lower shaft (Teflon) for 2000 ml
vessel with O-ring and spring, vessel with spring, numbered
numbered; for Low-Head use with certificate of compliance;
for High-Head use
89-000-6001 Basket holder with upper shaft
(integrated in drive head) and 84-040-6011 Basket holder with upper shaft
lower shaft (Teflon) for 1000 ml (integrated in drive head) and
vessel with spring, numbered lower shaft (Teflon) for 4000 ml
with certificate of compliance; vessel with O-ring and spring,
for Low-Head use numbered; for High-Head use

84-000-6012 Reduced price (elimination of 89-040-6001 Basket holder with upper shaft
upper shaft) when ordering in (integrated in drive head) and
addition to Paddles) lower shaft (Teflon) for 4000 ml
vessel with spring, numbered
with certificate of compliance;
2. UniShaft for High-Head use
Basket holders and shafts
84-000-6012 Reduced price (elimination of
84-010-6011 Basket holder with upper shaft upper shaft) when ordering in
(integrated in drive head) and addition to Paddles)
lower shaft (Teflon) for 1000 ml
vessel with O-ring and spring,
numbered; for Low-Head use

89-010-6001 Basket holder with upper shaft

(integrated in drive head) and
lower shaft (Teflon) for 1000 ml
vessel with spring, numbered
with certificate of compliance;
for Low-Head use

84-020-6011 Basket holder with upper shaft

(integrated in drive head) and
lower shaft (Teflon) for 1000 ml
vessel with O-ring and spring,
numbered; for High-Head use

89-020-6001 Basket holder with upper shaft

(integrated in drive head) and
lower shaft (Teflon) for 1000 ml
vessel with spring, numbered
with certificate of compliance;
for High-Head use

84-030-6011 Basket holder with upper shaft

(integrated in drive head) and
lower shaft (Teflon) for 2000 ml
vessel with O-ring and spring,
numbered; for High-Head use

72
Baskets; for UniShaft & MagniShaft
90-000-6040
USP Basket mesh 40, num-
bered

95-000-6040
USP Basket mesh 40, num-
bered with certificate of
compliance

90-000-6020
USP Basket mesh 20, num-
bered

95-000-6020
USP Basket mesh 20, num-
bered with certificate of
compliance

90-000-6010
USP Basket mesh 10, num-
bered

70-000-5004
Suppository Basket, plastic

73
USP apparatus 2 (Paddle)

1. MagniShaft
Paddles and Shafts
84-000-7001 Upper shaft 89-020-7001 Upper shaft (integrated in drive
(integrated in head) and lower shaft with
drive head) Paddle (Teflon), for 1000 ml
and lower vessel, numbered with certifi-
shaft with cate of compliance; for High-
Paddle Head use
(Teflon), for 1000 ml vessel,
numbered; for Low-Head use 84-020-7301 Upper shaft (integrated in drive
head) and lower shaft with Mini-
89-000-7001 Upper shaft (integrated in drive Paddle (stainless steel), for 250
head) and lower shaft with ml vessel, numbered; for High-
Paddle (Teflon), for 1000 ml Head use
vessel, numbered with certifi-
cate of compliance; for Low- 84-030-7001 Upper shaft (integrated in drive
Head use head) and lower shaft with
Paddle (Teflon), for 2000 ml
84-000-7301 Upper shaft (integrated in drive vessel, numbered; for High-
head) and lower shaft with Mini- Head use
Paddle (stainless steel), for 250
ml vessel, numbered; for Low- 89-030-7001 Upper shaft (integrated in drive
Head use head) and lower shaft with
Paddle (Teflon), for 2000 ml
vessel, numbered with certifi-
1. UniShaft cate of compliance; for Low-
Paddles and Shafts Head use

84-010-7001 Upper shaft 84-040-7001 Upper shaft (integrated in drive

(integrated in head) and lower shaft with
drive head) Paddle (Teflon), for 4000 ml
and lower vessel, numbered; for High-
shaft with Head use
Paddle
(Teflon), for 1000 ml vessel, 89-040-7001 Upper shaft (integrated in drive
numbered; for Low-Head use head) and lower shaft with
Paddle (Teflon), for 4000 ml
89-010-7001 Upper shaft (integrated in drive vessel, numbered with certifi-
head) and lower shaft with cate of compliance; for High-
Paddle (Teflon), for 1000 ml Head use
vessel, numbered with certifi-
cate of compliance; for Low-
Head use

84-010-7301 Upper shaft (integrated in drive

head) and lower shaft with Mini-
Paddle (stainless steel), for 250
ml vessel, numbered; for Low-
Head use

84-020-7001 Upper shaft (integrated in drive

head) and lower shaft with
Paddle (Teflon), for 1000 ml
vessel, numbered; for High-
Head use

74
Apparatus 5 USP apparatus 6
(Paddle over Disc) (Rotating Cylinder) UniShaft
1. MagniShaft 81-000-9000
Paddles and Shafts USP [Link] Rotating
Cylinder, short version,
84-050-7002 Upper shaft (integrated in drive to screw to Shaft; for
head) and lower shaft with Low-Head use
Paddle (Teflon) for USP 5,
numbered; for Low-Head use 86-000-9000
USP [Link] Rotating
89-050-7002 Upper shaft (integrated in drive Cylinder, short version,
head) and lower shaft with numbered with certificate of conformity, to
Paddle (Teflon) for USP 5, screw to Shaft; for Low-Head use
numbered with certificate of
compliance; for Low-Head use 81-000-9010
USP [Link] Rotating
84-000-6012 Reduced price (elimination of Cylinder, long version, to
upper shaft) when ordering in screw to Shaft; for Low-
addition to Paddles and/or Head use
Baskets)
86-000-9010
USP [Link] Rotating
Cylinder, long version,
2. UniShaft numbered with certificate of conformity, to
Spacers screw to Shaft; for Low-Head use

84-050-7003 Spacer to adjust standard Pad- 81-000-9001

dle system for USP method 5 USP [Link] Rotating Cylinder, short version, to
specified height screw to Shaft; for High-Head use

86-000-9001
USP method 5 Discs USP [Link] Rotating Cylinder, short version,
numbered with certificate of conformity, to
80-000-8040 EP method 5 specified disc, screw to Shaft; for High-Head use
125 m mesh size
81-000-9011
85-000-8040 EP method 5 specified disc, USP [Link] Rotating Cylinder, long version, to
125 m mesh size, numbered screw to Shaft; for High-Head use
with certificate of conformity
86-000-9011
USP [Link] Rotating Cylinder, long version,
numbered with certificate of conformity, to
screw to Shaft; for High-Head use

75
Enhancer Cell MagniShaft 84-060-4100 V-shaped Low-Head Vessel
Cover, plastic, for fixing
Enhancer cell, Teflon 80-000-7900 Felodipine Basket; additional
delivery
Enhancer cell
kit, Teflon, in- 84-061-4100 V-shaped Low-Head Vessel
cluding 250 ml Cover, Teflon, for fixing
round-bottomed Felodipine Basket; additional
vessel made of delivery
glass, Teflon
coated 84-160-4100 Low-Evaporation High-Head
[Link] mini-paddle and conversion kit to Vessel-Cover for fixing Felodip-
hold the 250 ml vessel; for High-Head use ine Basket
84-000-7900
Intrinsic Dissolution
Enhancer cell kit, Teflon, including 250 ml
round-bottomed vessel made of glass, Tef-
(Wood Apparatus) UniShaft only
lon coated [Link] mini-paddle and con-
version kit to hold the 250 ml vessel; for ERWEKA Wood
Low-Head use 84-000-7901 Apparatus with 10
mm surface area.
The tool includes
hardened punch,
Extraction cell controlled surface
area and improved
81-xx0-0000 The cell is described in EP die design.
2.9.4 Kap. 2 additional stirrer
required. Complete set including holder, punch, die,
intrinsic die and surface plate; for Low-
Head use 80-000-9900

Complete set including holder, punch, die,

intrinsic die and surface plate; for High-
Head use 80-100-9900

Manual Hydraulic Press for compaction of

the powder or granulate inside the con-
trolled surface area. Max. pressure force
10.0 tons 70-000-9900

Felodipine Basket (Stationary Bas-

ket) MagniShaft/UniShaft
Comprising of 1x Felodipine
Basket with Holder and 1x
V-shaped Vessel-Cover with
thread to screw Felodipine
Basket; for Low-Head use
84-000-4100 for 1000 ml
High Head use, comprising
of 1x Felodipine Basket with
Holder and 1x Vessel Cover with thread to
screw Felodipine Basket
84-100-4100

76
Dissolution Consumables Membrane Filters for Double Filtra-
tion System and AFC 825 Filter
Filters for manual and automated Changer
sampling
82-085-0101 1 Pack (200) of Filters, Mem-
To connect to automatic sampling station of DT brane 1m ROBY
90, DT 80, DT 70, DT 80, DT 700, DT 800, DT 82-085-0102 1 Pack (200) of Filters, Mem-
720 and DT 820 as well as for fixed sampling brane 0,7m ROBY
tubes and manual sampling manifold. 82-085-0103 1 Pack (200) of Filters, Mem-
brane 0,45m ROBY
70-000-2025 Set (25) of Filters, Poroplast,
1m
70-000-2100 Set (100) of Filters, Poroplast, Manual sampling manifold
1m
70-000-2999 Set (1000) of Filters, Poroplast, 10-096-0006
1m Manual sampling manifolds
70-000-3025 Set (25) of Filters, Poroplast, (basic) for ERWEKA Low
4m Head use. Comprising of sy-
70-000-3100 Set (100) of Filters, Poroplast, ringe and st. steel sampling
4m tube; 6x
70-000-3999 Set (1000) of Filters, Poroplast,
4m
14-096-0001
70-000-4025 For Low-Head Paddle use.
Set (25) of Filters, Consisting of a syringe, LUER
Poroplast, 10m connector, st. steel sampling
tube with height adjustment
70-000-4100 marks and adjustable holder
Set (100) of Filters, for USP/EP/JP compliant
Poroplast, 10m sample withdraw (midway
between top for paddle and
70-000-4999 surface of media)
Set (1000) of Filters,
Poroplast, 10m 14-096-0011
Ditto., but with Titanium sampling tube
70-000-5025 Set (25) of Filters, Poroplast,
20m 84-096-0001
70-000-5100 Set (100) of Filters, Poroplast, Additional [Link] sampling tube with marks
20m and holder for Low-Head Basket use.
70-000-5999 Set (1000) of Filters, Poroplast,
20m 80-096-0011
Ditto., but Titanium sampling tube
70-000-6002
Pre-Filters, st. steel, 14-096-0002
20m For High-Head Paddle use.
Consisting of a syringe, LUER
70-000-6005 connector, st. steel sampling
Pre-Filters, st. steel, tube with height adjustment
50m marks and adjustable holder
for USP/EP/ JP compliant
70-000-6001 sample with-
Pre-Filters, st. steel, 100m draw (midway between top for basket and sur-
face of media)

14-096-0012
Ditto., but with Titanium sampling tube

77
84-096-0002 Tubing and Connectors
Additional st. steel sampling tube with marks
and holder for High-Head Basket use. Teflon tubing, 1.6 mm o.d., 25 m
90-200-0016
84-096-0012
Ditto., but Titanium sampling tube Teflon tubing, 3.0 mm o.d., 25 m
90-200-0030
14-096-0006
Syringe connected to stainless steel sampling Verderprene tubing, 25 m
probe; for High- and Low-Head use 90-200-0020

10-096-0003 PEEK Tubing, 2.1 mm o.d., 25 m

Eppendorf Sampling 90-200-0021
Pipette for Low-Head
Dissolution Testers. Set (10) of tubing connectors for Teflon tub-
One-hand operation ing 1.6 mm o.d.
90-200-0116

Set (10) of tubing connectors for Teflon tub-

Sinkers ing 3.0 mm o.d.
90-200-0130
70-000-5000
Japanese Type
of sinker, [Link]
316, not magnetic, IQ/OQ/PVT documents for Dis-
set of 6 solution Testers and Dissolu-
tion Systems
66-064-9999 IQ/OQ/PVT documents for
70-000-5001 ERWEKA DT x20 Series
Spider Type of sinker, plas- 65-098-9999 IQ/OQ/PVT documents for
tics, set of 6 ERWEKA Flow-Through-Cell
Dissolution Tester, Type DFZ
70-000-5002 720/T
[Link] 316 wire, 50 m, diame-
ter 0.5 mm 75-203-x999 IQ/OQ/PVT document for Off-/
Online System

USP Reference Tablets and

Standards (PVT)

66-001-0001 1 bottle (30) of USP Reference

Tablets, Prednisone

66-001-0003 250 mg of Standard for Predni-

sone

78
Qualification tools for Dis-
solution Testers Manual
QA-Station
69-001-0011 80-124-0003
Standard Qualification (certified) Holder for former ERWEKA dissolution tester,
DT 70 / 80, DT 6 / /R to handle wobble meas-
Includes:
urement device, tachometer and spirit-level
- Electronic RPM meas-
uring unit
- Horizontal measure-
99-001-0001
ment tool
Electronic RPM meas-
- Wobble and centricity
urement unit, contact
measuring unit
less; including reflector
- Qualification tool for
marks (35)
height of method
- Digital Thermometer

90-001-0003
Spare Reflector Marks (35) for speed
Qualification Tool Kit for Mechanical Qualifica-
tion according to FDA (USP method 1 and 2,
certified) 70-001-0001
Horizontality measure-
Includes: ment tool
- Guidance adapter
- Digital level with
measurement
adapter
- Clamp for meter
(measurement of 75-002-0003
the wobble) Immersion
- Clamp for digital tachometer (measurement thermometer with
of the agitation speed) certificate
- Angular probe
- Digital gauge
- Measuring tips, extensions of meter, meas-
urement plate 85-001-0003
- Qualified UniShaft including actuator Digital thermometer
- Qualified MagniShaft with certificate
- Tool for stirring height
- Gap gauge
- Digital tachometer
- Reflection strip for tachometer
- Digital pocket thermometer 99-001-0002
- Disk Wobble and Cen-
- Hexagon wrench tricity measure-
UniShaft 69-002-1021 ment unit, certi-
MagniShaft 69-002-1121 fied

Qualification Tool Kit for Mechanical Qualifica-

tion Upgrade Kit without digital thermometer 95-001-0005
and electronic RPM measurement unit Qualification tool for
UniShaft 69-002-1031 height adjustment of
MagniShaft 69-002-1041 Basket, and Rotating
Cylinder, numbered
with certificate of con-
formity

79
Dissolution Tester (USP apparatus 3 and 7)
CALEVA BioDis
Dissolution Tester with 6, 7 or 8 rows
RRT 10 (for USP 3 use), with 6 rows, each 6
test positions + 2 reference position
230V/50Hz 72-226-0001
230V/60Hz 72-226-0002
115V/60Hz 72-226-0003
127V/60Hz 72-226-0004

RRT 10 (for USP 3 use), with 6 rows, each 7

test positions
230V/50Hz 72-227-0001
230V/60Hz 72-227-0002
115V/60Hz 72-227-0003
127V/60Hz 72-227-0004
The CALEVA RRT 10 is the perfect unit for
multiple media change and complies with USP RRT 10 (for USP 7 use), with 6 rows, each 6
apparatus 3 and method 7 (optionally test positions + 2 reference position
switchable without the need of tools, within 230V/50Hz 72-228-0001
approx. 1 minute). It is the perfect solution for 230V/60Hz 72-228-0002
multiple pH change due to the 6, 7 or 8 rows of 115V/60Hz 72-228-0003
vessels, 6 test stations and 2 reference posi- 127V/60Hz 72-228-0004
tions or 7 test stations (optionally) each. The
vessels are located in a heated water bath RRT 10 (for USP 7 use), with 6 rows, each 7
which is heated by an external heating system. test positions
The unique left to right movement allows easy 230V/50Hz 72-229-0001
access and visibility to each row. Additionally 230V/60Hz 72-229-0002
there is no software or head unit to attract cor- 115V/60Hz 72-229-0003
rosion. 127V/60Hz 72-229-0004
The RRT 10 is operated by a removable touch-
screen. Media loss by evaporation is prevented
by an automated covering system. Options, general
Optionally a sampling station for automation is RRT 10 for both, USP 3 and 7 use, switchable
available. by the user within minutes; automated recogni-
tion in which mode it works.
6, 7 or 8 rows, each with 6 stations and 2 Removable user interface for control by touch
vials for reference purposes, optionally 7 screen instead software for PC operation.
test-stations of the same capacity
Cylindrical flat bottomed glass vessels 300 th
7 row 72-22x-1xxx
ml (media volume) for USP method 3 th th
7 and 8 row 72-22x-2xxx
Glass reciprocating cylinders fitted with
mesh screens top and bottom
Speed adjustable from 5-40 strokes/min.,
accuracy better than +\- 0.5%, height of USP 3 Options
stroke 100 mm (USP 3) and 20 mm
(USP 7) 1000 ml conversion kit
Acrylic glass water bath, 6 mm Comprising of 4x 3 1000 ml vessel, 12x
Agitator shafts made of 316 stainless steel, adaptor for rack, 12x evaporation cover and
vessel racks in Teflon coated stainless steel 12 adaptors for vessel 82-226-1003
Cylinders will automatically centre inside
the vessels
Evaporation losses are prevented by a
covering system
Internal machine software permits manual
control of the unit through the portable
touch screen. Increasing levels of offline
automation are available through the inter-
nal software but further online automation is
available using a PC with Windows Soft-
ware.

80
USP 7 Options Qualification
1000 ml conversion kit IQ/OQ/PVT Document 66-121-9999
Comprising of 4x 3 1000 ml vessel, 12x
adaptor for rack, 12x evaporation cover and
12 adaptors for vessel 82-226-1007 IQ/OQ/PVT tool kit, certified (includes: Digi-
tal Tachometer, Calibrated Thermometer,
100 ml conversion kit Steel Ruler, Stopwatch)
Comprising of 48x 100 ml vessel, 48x adap- 65-121-0000
tor for rack, 48x evaporation cover and 48
adaptors for vessel 82-226-0107 Bottle (60) Chlorpheniramine Maleate Tab-
lets 85-120-0000
50 ml conversion kit comprising of 48x 50 ml
vessel, 48x adaptor for rack, 48x evapora- 1 Set = 60 Tablets USP Chlorpheniramine
tion cover and 48 adaptors for vessel Maleate extended Release Tablets
82-226-0057 85-120-0001

Spring Holder, USP, 1.45 inch (for use with 1 Set = 125 mg USP Chlorpeniramine
300 and 1000 ml vessels) 82-226-7001 Maleate Standard 85-120-0003

Spring Holder, USP, 1.40 inch (for use with

50, 100, 300 and 1000 ml vessels)
82-226-7002

Spring Holder, USP, 0.96 inch (for use with

50, 100, 300 and 1000 ml vessels)
82-226-7003

Spring Holder, USP, 0.60 inch (for use with

50, 100, 300 and 1000 ml vessels)
82-226-7004

Acrylic Rod, USP (for use with 50, 100, 300

and 1000 ml vessels) 82-226-7005

Cylinder Transdermal Holder, USP (for use

with 300 and 1000 ml vessels)
82-226-7006

Reciprocating Disc, USP, 1.6 cm (for use

with 50, 100, 300 and 1000 ml vessels)
82-226-7007

Reciprocating Disc, USP, 2.5 cm (for use

with 100, 300 and 1000 ml vessels)
82-226-7008

Reciprocating Disc, USP, 5.0 cm (for use

with 300 and 1000 ml vessels)
82-226-7009

Reciprocating Disc, USP, 7.0 cm (for use

with 300 and 1000 ml vessels)
82-226-7010

Angeled Disc, USP, 1.98 inch (for use with

1000 ml vessels) 82-226-7011

Angeled Disc, USP, 1.42 inch (for use with

300 and 1000 ml vessels) 82-226-7012

81
Dissolution Tester (USP apparatus 4)
ERWEKA DFZ 720 ERWEKA USP apparatus 4
Flow-Through-Cell with 7 stations Pump, HKP 720
according to USP apparatus 4

The ERWEKA DFZ Dissolution Testers offer The valve-free ERWEKA Piston Pump HKP 720
the typical advantages of USP apparatus 4 but is specially designed for the use with USP ap-
eliminate the typical disadvantages. paratus 4 Flow-Through-Cell. In standard con-
ERWEKA designed a new valve-free pump with figuration it offers a flow rate from 2.0 ml to 32.0
automatic deaeration and volume adjustment. ml at 120 strokes/minute and an accuracy of
5%. Unlike other USP 4 pumps the HKP 720
DHC 2000i flow heater with 2 temp. sen- offers automated deaeration at the start of the
sors, 1x internal and 1x external for the operation.
water bath The required flow rate is just pre-set by the
Water distribution system integrated menu and the HKP 720 will adjust
One three-way valve for control of the wa- the requested flow rate by itself.
ter flow There are no valves incorporated in the HKP
Plastic support plate for the cells 720 to eliminate the problems of particles stick-
Deep drawn tray water bath + metal hous- ing.
ing incl. view window
Immersion thermometer for control of the 7-channels
temperature in the water bath Valve-free design
Quick-Screw closing system for the cells Automatic deaeration of the pump heads
Teflon tubing 1.6 mm or 3.0 mm o.d. Pump heads made of Teflon and ceramics
High Accuracy (5 %)
7 Cell type with immersion thermometer to Automatic flow rate adjustment
control the temperature in the water bath Parallel printer interface for documentation
of strokes/min.
7 cell type, Serial RS 232 interface for external control
excluding cells Teflon tubing

Flow rate from 2.0 to 32.0 ml/min at 120

strokes/min., Teflon tubing 1.6 mm o.d.
100-240V/50-60Hz 10-312-1200
230V/50Hz 13-012-0001
230V/60Hz 13-012-0002 Spare Part Kit for HKP 720 90-312-xx00
115V/60Hz 13-012-0003
127V/60Hz 13-012-0004

The DFZ is without cells. The cells can be

selected under options

82
Options
Peristaltic Pump for Low-Flow Filters for Flow-Through-Cell
Filter for USP 4; 0.7 m; 25 pcs; 15 mm
70-212-1507

Filter for USP 4; 1.4 m; 25 pcs; 15 mm

70-212-1514

Filter for USP 4; 0.7 m; 25 pcs; 22 mm

70-212-2207

Filter for USP 4; 1.4 m; 25 pcs; 25 mm

70-212-2214

The standard ERWEKA 8-channel Peristaltic

Glass beads
Pump for transfer of the sample from the
Granulate Set with beads 1mm and 6mm,
media container through the test-stations of
200mg 80-212-1300
the Flow-Through-Cell Dissolution Tester.
The media flow rate can be chosen by the
speed of the pump as well as Off-times (foil ph change valve
keys and LC display).
The pump can either be controlled stand Manual switching valve for pH
alone, by the SE or by the ERWEKA media change
[Link] software via the RS 232 serial in- 80-012-0000
terface.

8-channel Peristaltic Pump

Accuracy of volume 15%
RS 232 serial interface
Touch sensitive keys and LC display
Verderprene tubing for elimination of Electronic switching valve for up to 1 media
absorption of active ingredients by PVC changes (only in combination with System Con-
tubing trol Unit, type SE) 80-012-0003

230V/50Hz 11-202-5001 Electronic switching valve for up to 3 media

230V/60Hz 11-202-5002 changes (only in combination with System Con-
115V/60Hz 11-202-5003 trol Unit, type SE) 80-012-0003
127V/60Hz 11-202-5004
Online Deaeration Device (only in the pH range
of 4 to 6.5) 80-012-0004
Media Transfer Station, Type LMT, to create
a Close-Loop system.
Thermostatically heated water bath with 6x
1000 ml beaker glasses, stand with mag-
netic stirrer for each beaker glass, Teflon
tubing 80-012-1000

Splitter (from one tube to seven tubes)

80-012-0005

83
80-012-0007 Media temperature measurement in each
Set (7) of USP 12.0 mm cell by integrated electronic PT 100 tem-
Cell perature sensors (temperature displayed
and printed by Control Unit, Type SE)
10-013-xxxx

Media Transfer Station, Type LMT, to cre-

ate a Closed Loop system. Thermostati-
cally heated water bath with 6x 1000 ml
beaker glasses, stand with magnetic stirrer
for each beaker glass, Teflon tubing
80-012-1007 80-012-1000
Set (7) of USP 22.6 mm
Cell Seven three-way valves for individual con-
trol of each cell. Test-stations arranged in
line 13-01x-x1xx

Tubing, Teflon 3.0 mm o.d.

10-01x-xx1x

Water Stabiliser with colour indicator,

1 bottle 80-080-0002

Set (7 pcs.) off USP Tablet holders

80-012-2007 Typ A for 22.6 mm Cell 80-012-0016
Set (7) of PhEur 2.9.42 Typ B for 12.0 mm Cell 80-012-0017
Suppository Cell

80-012-3007
Set (7) of USP Granulate
& Powder Cell

80-012-4007
Set (7) of USP Implant
Cell

84
Dissolution Systems
ERWEKA Dissolution System Open - Loop Offline Kit
(storage and control only)

1. USP apparatus 4 Dissolution 2. System Control Unit, Type

Tester SE
The System Control Unit allows controlling
1. Autosampler FRL 704 automated Media Change Valve Unit (up to 3
media changes), HKP 720 USP 4 compliant
The ERWEKA USP 4 Piston Pump and Fraction Collector FRL 704.
Fraction Collector, The System Control Unit allows storing test-run
Type Autosampler parameters for up to 40 different products which
704 allows collection may be recalled for testing. The Unit comes
of an average of the with alpha-numeric membrane keypad and
flow-through in max. illuminated LC display. For documentation pur-
16 intervals from up pose a standard printer may be connected.
to 6 or 7 test stations
(max. 25 ml each). Via the system control unit,
type SE; all sample parameters can be entered.
3. System Pre-Configuration
Control and pre-configuration of the complete
Collection of an average by valves system at the ERWEKA laboratory. Control of
Collects from up to 7 test stations; max. 16 function and numbering of all tubes and inter-
sampling cycles face cables for easy connection at the custom-
Rack for 16x 8 samples (only 6 rows us- ers site.
able with DFZ 720) with glass tubes, 25 ml
RS 232 and RS 485 interfaces for external
control
4. System Tubing
Interface for USP 4 Pump
System tubing, complete with tubing and con-
nectors, Teflon 1.6 mm o.d.
Racks
!!!Open-Loop Offline Kit System Price in-
Rack for 16x 8, glass tubes of 25 ml volume cludes the FRL 704/SE kit (incl. 25ml rack,
tubing, pre-configuration. The DFZ and the
HKP must be selected additionally)

230V/50Hz 71-010-0001
230V/60Hz 71-010-0002
115V/60Hz 71-010-0003
127V/60Hz 71-010-0004

85
Options

1. Racks
Rack for 24x 8 HPLC vials of 4.0 ml vol-
ume 80-200-0002

Rack for 16x 8 glass tubes of 10 ml volume

80-200-0004

2. ph change valve
Manual switching valve
for pH media change
80-012-0000

Electronic switching valve for up to 1 me-

dia changes 80-012-0003

Electronic switching valve for up to 3 me-

dia changes 80-012-0004

86
ERWEKA Dissolution System Closed - Loop Offline Kit
(to complete the DFZ Closed Loop system required one; HKP, LMT, DFZ)

1. Autosampler 3. Peristaltic Pump

The ERWEKA stan- The standard
dard USP 4 Fraction ERWEKA 8-channel
Collector, Type FRL Peristaltic Pump for
804 allows sampling transfer of the sam-
up to 16 sampling ple from the media
cycles (up to 25 ml container to the
each). Via the Flow-Through-Cell
system control unit, type SE; all sample pa- Dissolution Tester.
rameters can be entered. The media flow rate can be chosen by the
speed of the pump as well as Off-times (foil
Precision Dosing by a valve system keys and LC display). The pump can either be
Media replacement possible controlled stand alone, by SE or by the
HPLC Vial membrane piercing ERWEKA Dissolution Software via the RS 232
Up to 24 sampling cycles serial interface
Rack with 8 rows x 24 samples with HPLC
vials 1,2 ml volume (optional 4.0 ml or glass 8-channel Peristaltic Pump
tubes) RS 232 serial interface
Interfaces for external control Touch sensitive keys and LC display
Interface for USP 4 Pump Verderprene tubing for elimination of ab-
sorption of active ingredients by PVC tubing
Rack for 24x 8 HPLC vials of 1,2 ml volume

2. System Control Unit, type SE 4. System Pre-Configuration

The System Control Unit allows to control Control and pre-configuration of the complete
automated Media Change Valve Unit (up to 3 system at the ERWEKA laboratory. Control of
media changes), HKP 720 USP 4 compliant function and numbering of all tubes and inter-
Piston Pump and Fraction Collector FRL 804 as face cables for easy connection at the custom-
well as display of media temperatures inside ers site.
the vessel (DFZ 720T only).
The System Control Unit allows storing test-run
parameters for up to 40 different products which
may be recalled for testing. The Unit comes 5. System Tubing
with alpha-numeric membrane keypad and
illuminated System tubing, complete with tubing and con-
LC display. For documentation purpose a stan- nectors, Teflon 1.6 mm o.d.
dard printer may be connected.

87
6. Media Transfer Station LMT
Media Transfer Station, Type LMT, to create
a Close- Loop system.
Thermostatically heated water bath with 7x
1000 ml beaker glass, stand with magnetic
stirrer for each beaker glass, Teflon tubing
80-012-1000

!!! Closed-Loop-Offline Kit System price

includes the IPC/FRL 804/SE Kit (incl. rack
for 25x 8 1.2 ml HPLC vials rack, tubing, pre-
configuration). The DFZ, HKP and LMT must
be selected additionally!!!

230V/50Hz 72-020-00x1
230V/60Hz 72-020-00x2
115V/60Hz 72-020-00x3
127V/60Hz 72-020-00x4

Options

1. Autosampler
Additional price for media replacement, incl.
two integrated 1-channel peristaltic pumps
and a two-section acrylic glass container
15-xx8-xxx1

2. Racks
Rack for 24x 8 HPLC vials of 4.0 ml
Volume 80-200-0002

Rack for 24x8, with glass tubes of 10 ml

volume 80-200-0003

Rack for 16x 8, with glass tubes of 25 ml

volume 80-200-0004

88
ERWEKA Dissolution System Closed-Loop UV-VIS Online Kit
(to complete the DFZ Closed Loop system required one; LMT, HKP, DFZ)

1. UV-VIS Spectrophotometer 4. System Pre-Configuration

Shimadzu 1800 Control and pre-configuration of the complete
double beam in- system at the ERWEKA laboratory. Control of
cluding 8 position function and numbering of all tubes and inter-
cell changer, ready face cables for easy connection at the custom-
for Online Systems ers site.
excl. Cuvettes
5. Media Transfer Station LMT
Media Transfer Station, Type LMT, to create a
2. Dissolution System Soft- Close-Loop system.
ware Thermostatically heated water bath with 6x1000
ml beaker glasses, stand with magnetic stirrer
Windows based CFR 21/11 compliant for each beaker glass, Teflon tubing
ERWEKA Dissolution System Software 80-012-1000
Recommended PC configuration:
- Processor: Pentium IV 1.2 GHz 6. Peristaltic Pump
- Memory: 256 MB, HDD free space: 300 MB
- Operating system: MS Windows 2000 Pro- The standard ERWEKA 8-channel Peristaltic
fessional or MS Windows XP Professional Pump to withdraw samples from the media
- Screen resolution: 1024x768 (minimal), transfer containers
1280x1024 (recommended) (inside the LMT) to
the flow-through
cuvettes of the UV-
3. System Tubing Vis.

System tubing, complete with tubing and con-

nectors, Teflon 1.6 mm o.d., configured as
Inline-System (return to vessel after analysis). !!! Close-Loop UV-VIS Online Kit System
price includes the Shimadzu 1800, IPC,
Software, Tubing, pre-configuration !!!

230V/50Hz 71-030-x5x1
230V/60Hz 71-030-x5x2
115V/60Hz 71-030-x5x3
127V/60Hz 71-030-x5x4

89
Options 8-channel Syringe Pump
8 electric 4-way valves, absorption free
Hamilton syringes 25 ml
1. UV-VIS Spectrophotometers Accuracy of volume 0,1 ml (25 ml sy-
ringes)
ERWEKA SPM RS 232 serial interface
double beam in- Teflon tubing
cluding 8 position 71-030-xx1x
cell changer, ready
for Online Sys-
tems.
Additional price, instead Shimadzu 1701 4. Cuvettes for UV-VIS
incl. Cell Changer
With Teflon Tubing (0.8 mm o.d.) and screw-
230V/50Hz 71-030-01x1 fittings. For 8-position cell changers
230V/60Hz 71-030-01x2
115V/60Hz 71-030-01x3
127V/60Hz 71-030-01x4

2. UV-VIS Spectrophotometers
ERWEKA SPM
double beam in-
cluding 16 position
cell changer, ready
for Online Sys-
tems. 1x Path Length 10 mm 80-203-0010
Additional price, instead Shimadzu 1701 1x Path Length 5 mm 80-203-0005
incl. Cell Changer 1x Path Length 2 mm 80-203-0002
1x Path Length 1 mm 80-203-0001
230V/50Hz 71-030-02x1
230V/60Hz 71-030-02x2
115V/60Hz 71-030-02x3
127V/60Hz 71-030-02x4 5. ph change valve
Electronic switching valve for
3. Sample Transfer Pump, up to 1 media changes
SP 725/25 (Syringe Pump) 80-012-0003
The ERWEKA 7-
channel Syringe Pump,
Type SP 725/25 ml sy-
ringes is the ideal me-
dia transfer pump for all
kind of Dissolution Sys-
tems. It offers very ac-
curate volume flow,
elimination of absorp-
tion (glass/Teflon) and
high flexibility due to an electric 4-way valve
at the in-/outlet of each syringe. This unique
design allows performing all needed steps
for the Dissolution Test, even dilution, media
replacement and transfer from the Fraction
Collector to an UV-VIS system with only one
pump! The SP 725/25 is equipped with a RS
232 interface for control by the ERWEKA
[Link] software.

90
Dissolution Media Preparation and Dosing
ERWEKA MediPrep 120 Media Tank
ERWEKA Media Pre-
Heating Tank MT66,
MT120, and MT160 (for
connection to MediPrep
120). For your media
storage ERWEKA of-
fers tanks made of
Polyethilen or [Link]
(66 l, 120 l, or 160 l
volume
other sizes on request.) The tanks pre-heat the
media and can be moved around the laboratory
on 3 diameter casters. Media is heated by
means of the integrated 1.500 Watts (at 230V)
electronic flow through heater (therefore no
stirring is required). Temperature is adjustable
between 10C and 50C, temperature display.

Options
Dissolved oxygen meter 80-099-6200

IQ/OQ/PQ document 65-099-9999

The new bench top degasser from ERWEKA
offers pre-heating, degassing and dosing of MT 66 Media Tank 80-099-6300
dissolution media. Dispense volumes selected
from 250 ml to 1.000 ml can be chosen in steps MT 120 Media Tank 80-099-6400
of 10 ml with an accuracy better than 1%. The
media is dispensed by weight using the new MT 160 Media Tank 80-099-6500
load cell. Nominal degassing time of 1m 30 sec.
for 1.000 ml of heated media means a 6 station Transformer for MediPrep 120 (from 110V to
test can be prepared in less than 10 min. from 230V) 80-099-6600
cold media storage.
Degassing is better than 5.5 ppm. A printer is Glass rack for up to 3 vessels
included for calibration and test print results. 80-099-6700
Easy to use menus guide the user through each
operation making media preparation easier and
quicker than ever. No waiting for media tanks to
heat up. Media changes are quick via the flush
routine.

230V/50Hz 70-099-6001
230V/60Hz 70-099-6002
115V/60Hz 70-099-6003
127V/60Hz 70-099-6004

91
ERWEKA MultiPrep
Technical Data
Display/Keypad: 4-line LCD/ Numeric touch pad
with additional function keys Printer/Interface:
parallel Memory: 60 methods/ 11 users Con-
tainer volume: 18 litre Media types: almost all,
including HCI solutions Dispencing volumes:
500ml, 750ml, 900ml, 1000ml
Dispencing accuracy: +/-1%
Temperature range: 30C 50C
Temperature accuracy: +/- 0,5C
Vacuum: max. 800 mbar
Dosing: volumetric
Mixing: gravimetric
The new degasser from ERWEKA offers pre- Preparing time for 8 x 1000ml Vessels: approx.
heating, degassing and dosing of dissolution 5min
media according to recommendations and regu- Dimensions: W413mm x D990mm x H720mm
lations of USP, EP, FDA, GLP/GMP. Weight: Net 85kg
The fully automated MultiPrep cleans itself
automatically and it is a compact unit which can
be easily connected to other dissolution devices
via the ERWEKA [Link] software or can
run as standalone. The easy to use menus are
Options
designed to guide users through every process.
The process can be monitored via the LCD IQ/OQ/PQ Documents
display and the numeric touch sensitive keypad 65-099-9998
with additional function keys.
Spare Part kit, including water filter, fuses
Automatic mixing of media using de-ionised and hose nozzle 91-099-0001
water and a mix of up to 6 concentrates
Usage of up to 2 pre-mixed media Printer for documentation 80-120-0009
Degassing of the applicable media allows a
minimum oxygen, leading to reliable test re- Security valve with cable and plug connec-
sults tor to avoid damage caused by turned on
Preparation and storage of up to 18 litres of water tap 70-012-0003
media at a constant temperature of 37C
8 separate pumps and tubings support the Transformator to convert voltage (from
simultaneous filling of up to 8 vessels at the 110V into 230V) 80-099-6010
same time, ensuring identical process condi-
tions
Thanks to internal memory up to 60 methods
and up to 11 user profiles can be saved,
making the process more transparent
Load cell locking enables transportation
without damaging the balance
Fully automatic flush (cleaning) routine using
water and washing liquid. Programmed to
clean container and tubings before and after
every test preventing possible damage from
aggressive acids.
Completely menu guided calibration. Easy
Qualification due to built-in balance.
Qualification kit incl. weight 500g, weight
1kg, carrying case, screwdriver, tube and fil-
ter

230V/50Hz 70-099-7001

92
 Upper jaw: Revolving according to the re-
Chewing Gum Tester DRT volving device, no up and down move-
ments
- Mounted on a heat insulated holder
- Can be easily removed for cleaning or
changing (recommended after each test)
- Distance of upper and lower jaw in closed
position adjustable between 0-10 mm
- Acid proofed stainless steel with blasted
surface for a better grip
Lower jaw: Lifting according to the device
for up and down movements
- No sliding of the sample during mastication
due to the design of the jaw and due to
separate nets between the jaws
- Metal in contact with lower jaw tempered
by the circulated water
- Acid proofed stainless steel with blasted
surface for a better grip
- Can be easily removed for cleaning or
changing. We recommend cleaning or
changing the jaw after each test run
Device for movements: Vertical pneumatic
cylinder, compressed air 6-8 bar, com-
pressed air supplied by the customer*
Test equipment to masticate chewing gums, - Movement frequency adjustable between
especially medicated ones for the in vitro re- 20 - 60 cycles per minute
lease of substances from the samples into a Temperature controlled water bath can be
surrounding liquid medium. regulated between 25 45 C.
- One water bath for up to 6 test cells, vol-
Up and down strokes (vertical) of the lower jaw
ume 25 litres, made of PMMA acrylic
in combination with a revolving movement of
glass.
the upper jaw which provides mastication of the
- Electronic pump for continuous circulation
chewing gum and at the same time an agitation
of the heated water.
of the test medium.
Mobile carrier for easy transport of the
For manual sampling, emptying and cleaning whole equipment. Two level carrier with
process the lower jaw with the test cell can be rubber wheels. Made of aluminium
lowered into the down position and the chewing Electronic control of each test cell individu-
process stops. The test cell, the upper and ally
lower jaw can be easily removed. Control of movement frequencies, opera-
tion time, temperature and warming up pe-
The temperature of the water in the test cell
riod, no product memory, parallel and se-
around the media will be controlled by a water
rial interface available currently
circulation system.
Power 230 VAC, 50/60Hz, 1000 VA (W)
1 (DRT 1) or 6 test stations (DRT 6)
Revolving device for upper jaw:
- Pneumatic drive unit, compressed air 6-8 Special models with logging of pressure,
bar, compressed air to be supplied by cus- torque, pH and temperature are available.
tomer Customized models equipped for extra hard
- The angle of the revolving movement can gums or with extended volume for sparingly
be adjusted between 10 180 soluble substances etc are available on re-
Test Cell: Double-walled and made of quest.
glass which allows visual inspection during
the test .
- Volume for dissolution medium 20-70 ml
- Temperature controlled by a water circula-
tion system
- In- and outlet nozzle for the water circula-
tion system, Test Cell can be easily re-
moved for cleaning or changing.

93
DRT 1 with 1 test station Options for DRT
230V/50Hz 12-091-0001
230V/60Hz 12-091-0002 1000 pcs. Nets, extra 82-090-0003
115V/60Hz 12-091-0003
127V/60Hz 12-091-0004 100 pcs. 50 upper and 50 lower test jaws
82-090-0001
DRT 2 with 2 test stations
Cuvette, extra 82-090-0010
230V/50Hz 12-092-0001
230V/60Hz 12-092-0002 Cuvette, straight 82-090-0009
115V/60Hz 12-092-0003
127V/60Hz 12-092-0004 Compressor Type Fini
DRT 3 with 3 test stations 230V/50Hz 82-090-0011
230V/50Hz 12-093-0001 230V/60Hz 82-090-0012
230V/60Hz 12-093-0002 115V/60Hz 82-090-0013
115V/60Hz 12-093-0003 127V/60Hz 82-090-0014
127V/60Hz 12-093-0004 Compressor, Type Jun-Air, 32 l.
DRT 4 with 4 test stations 230V/50Hz 82-090-0021
230V/60Hz 82-090-0022
230V/50Hz 12-094-0001 115V/60Hz 82-090-0023
230V/60Hz 12-094-0002 127V/60Hz 82-090-0024
115V/60Hz 12-094-0003
127V/60Hz 12-094-0004
Compressor, Type Jun-Air, 64 l.
DRT 5 with 5 test stations 230V/50Hz 82-090-0031
230V/50Hz 12-095-0001 230V/60Hz 82-090-0032
230V/60Hz 12-095-0002 115V/60Hz 82-090-0033
115V/60Hz 12-095-0003 127V/60Hz 82-090-0034
127V/60Hz 12-095-0004
Blasting cleaning qualification (each pair)
82-090-0002
DRT 6 with 6 test stations
Spare Part Kit consists of extra cuvette and
230V/50Hz 12-096-0001 o-rings, a pair of blank upper jaws and tools.
230V/60Hz 12-096-0002 91-090-0000
115V/60Hz 12-096-0003
127V/60Hz 12-096-0004 IQ / OQ document 66-090-9999

Qualification tool kit 66-090-0000

Jaw setting gauge 82-090-0004

94
Automatic Blasting Station Semi-Automatic Cleaning
Measures: approx
Station
0.6 x 0.8 m, height
0.6 m. Measures:
Cylindric drum with a di-
Demands on sup- ameter of approx 0.6 m,
ply: height 0,3 m. A crank
compressed air 6- and gearbox is con-
8 bar, 100 li- nected to the side of the
tres/min at 6 bar, drum.
compressor, res-
ervoir of 50-100 li-
tres.
Power supply 100-240 VAC, 50/60 Hz, less Demands on supply:
than 1 A. Blaster sand: Aluminium dioxide 0.2 The cleaning station is for manual operation in
0.4 mm, 1.5 kg per batch of 18 pair of jaws. a ventilated hood or cupboard (basket funnel).
Acetone: 2 litres water free Acetone from a
The Automatic Blasting Station needs a venti- normal freezer is used at - 20 C for each batch
lating hood or exhaust for dust that is formed of 18 pair of jaws. The Acetone may be reused
during the blasting procedure. Small amounts of many times.
blaster sand may fall on the floor during the
filling procedure. The station should not be
placed in the analytical lab. An ultrasonic water
bath is needed for final
Instruments for thickness measurements and cleaning with deionised
surface roughness are needed to control the water and Acetone (Pro
jaws and to qualify them before use. Analysi) after the blast-
ing procedure.
230V/50Hz 72-090-0001 72-091-0001
230V/60Hz 72-090-0002
115V/60Hz 72-090-0003
127V/60Hz 72-090-0004

95
Detergents Tester (Tergotometer)
ERWEKA RT 700
Acrylic Glass Water Bath (only 2.000 ml
version)
External Flow-Through Thermostat, accu-
racy +/- 0.2C
PT 100 electronic temperature sensor
(one-point calibration), cooling/heating of
the Water Bath between 10-45C
-1
Agitation Speed up to 300 min
Direction of rotation alterable can be
changed after a freely adjustable break
Self-Centering Vessels
Detergents Tester RT 700 is versatile labora- USP stainless steel Shaft and Paddles or
tory test equipment with which the washing Baskets
process of a common washing machine / dish- Wobble < 0.2 mm
washer can be simulated, in order to determine Vibrations < 0.1 mils
different quality parameters of cleaning agents Teflon Coated Vessel Support Plate
(tabs). 80 Digit 4-line LC Display, illuminated
The RT 700 is equipped with 7 test stations with Numeric Membrane Keypad with additional
1.000 ml or 2.000 ml glass vessels and a fur- Function Keys
ther station into which the supply of the immer- Acoustic and Optic Manual Sampling Re-
sion cooler is integrated. The glass vessels are minder
integrated into a water bath, which can be Test-Run Duration Count-Up or Count-
heated depending upon test requirements up to Down
45C or cooled down to 10C. The regulation of Serial RS 232 Interface
the temperature takes place via the combina- Parallel Printer Port
tion of a flow heater and a cooler. If the immer-
sion cooler is not needed, it can be removed. ERWEKA RT 706 HH/1.000 ml
Thereby an eighth test station becomes free. 230V/50Hz 11-077-6001
Each of the 7 test stations allows paddles to 230V/60Hz 11-077-6002
simulate the agitating movement of a washing 115V/60Hz 11-077-6003
machine/dishwasher. The unit can be driven 127V/60Hz 11-077-6004
-1
with up to 300 min . The direction of rotation
ERWEKA RT 706 HH/2.000 ml
can be changed after a freely adjustable break,
230V/50Hz 11-177-6001
and thus the washing process is simulated op-
230V/60Hz 11-177-6002
timally.
115V/60Hz 11-177-6003
Using the adjustable test parameters of the RT
127V/60Hz 11-177-6004
700 such as temperature, rate of motion and
duration of the test, most different test stan- ERWEKA RT 707 HH/1.000 ml
dards currently used by manufacturers of clean- 230V/50Hz 11-077-7001
ing agents and dishwashers can be tested. In 230V/60Hz 11-077-7002
each test the structure of the cleaning solution, 115V/60Hz 11-077-7003
degree of water hardness, pH value, chloride, 127V/60Hz 11-077-7004
etc., can be varied.
ERWEKA RT 707 HH/2.000 ml
RT 700-1000/HH with 1.000 ml Vessels 230V/50Hz 11-177-7001
RT 700-2000/HH with 2.000 ml Vessels 230V/60Hz 11-177-7002
6 (DT 706) or 7 (DT 707) test stations 115V/60Hz 11-177-7003
OQ Traffic Light for temperature, Qualifi- 127V/60Hz 11-177-7004
cation-, Calibration and Service Intervals
(standard). RPM and height (optional) Options
Calibration Interval Display
Qualification Interval Display Cooling Device Type FT 200 (control of the
Service Interval Display cooling device is done by the ERWEKA DH
Online System Suitability Test Menu and 2000 Thermostat) 11-x77-x1xx
protocol
Moulded 1-piece PET water bath (only Modifications to accept speed of max. 300
1.000 ml version) rpm, clockwise and anti-clockwise directions
External immersion thermometer with pause time, pre-selectable
11-x77-xx1x

96
Disintegration Testers
ERWEKA ZT 120 Series Options
Basket Cleaning and Media Preheat Station
(ZT 121/123 only) 11-25x-x1xx

USP compliant Quick-Clean Basket Rack

Assembly instead standard version. The
Quick-Clean Baskets allows cleaning of
the test stations from Tablet leftovers with-
out the need of disassembling tools.82-24x-0006

Basket Rack Assembly, Type B, with 3

test-stations 82-240-0011

Basket Rack Assembly, Type B, with 3

test-stations in Quick-Clean Version
The basic ERWEKA disintegration tester is
82-240-0016
represented by the ZT 120 series, available
with 1, 2, 3 or 4 simultaneously operating
Immersion thermometer 70-001-0003
USP/EP/JP compliant test stations. Lift in and
lift out of the baskets is performed manually. Immersion Thermometer, certified Version
Test time and nominal bath temperature is en-
75-001-0003
tered via the membrane keys, current test time
as well as actual water temperature are shown
Water Stabiliser with colour
on clearly visible red LEDs.
indicator, 1 bottle
On request, an alarm may be selected to sound
80-080-0002
upon completion of the preset test time.
Heating of the warming solution in the moulded
1-piece PET water bath is performed by an
integrated flow-through heating system.

1 to 4 test racks
30 1 strokes/min. Spare part kit for ERWEKA ZT 120 Series
55 2 mm stroke height 92-240-0000
Manual lift out
Spare Part Kit for standard basket rack
1 Test Station, Type ZT 121 92-240-0001
230V/50Hz 12-241-0001
230V/60Hz 12-241-0002 Spare Part Kit for Quick Clean basket rack
115V/60Hz 12-241-0003 92-240-0002
127V/60Hz 12-241-0004
IQ/OQ/PQ documents for ZT 120/220/ 320
2 Test Stations, Type ZT 122 Disintegration Tester 65-2x0-9999
230V/50Hz 12-242-0001
230V/60Hz 12-242-0002
115V/60Hz 12-242-0003
127V/60Hz 12-242-0004

3 Test Stations, Type ZT 123

230V/50Hz 12-243-0001
230V/60Hz 12-243-0002
115V/60Hz 12-243-0003
127V/60Hz 12-243-0004

4 Test Stations, Type ZT 124

230V/50Hz 12-244-0001
230V/60Hz 12-244-0002
115V/60Hz 12-244-0003
127V/60Hz 12-244-0004

97
ERWEKA ZT 220 Series Options
Basket Cleaning and Media Preheat Station
(ZT 221/223 only) 12-25x-x1xx

USP compliant Quick-Clean

Basket Rack Assembly in-
stead standard version. The
Quick-Clean Baskets allows
cleaning of the test stations
from Tablet leftovers without
the need of disassembling
tools
82-241-0006

Basket Rack Assembly, Type B, with 3

In contrast to the ZT 120 series, on the ZT 220
test-stations 82-240-0011
series (available 1 to 4 test stations, operating
simultaneously) the counting of the elapsed test
Basket Rack Assembly, Type B, with 3
duration is automatically started/ stopped when
test-stations in Quick-Clean Version
the arm with the basket is lowered/raised 82-240-0016
manually.
Water Stabiliser with colour
1 to 4 test racks
indicator, 1 bottle
30 1 strokes/min. 80-080-0002
55 2 mm stroke height
Function keys and 2x LE display for enter-
ing nominal bath temperature and required
run-time
Starts/stops to count run-time automati-
cally when basket rack is lowered
Optional acoustic alarm on the completion Immersion thermometer 70-001-0003
of the pre-set run-time
Manual lift-in and -out of the Baskets Immersion thermometer in certified version
with certificate 75-001-0003
1 Test Station, Type ZT 221
230V/50Hz 12-251-0001 Spare part kit for ERWEKA ZT 220
230V/60Hz 12-251-0002 Series 92-250-0000
115V/60Hz 12-251-0003
127V/60Hz 12-251-0004 Spare Part Kit for basket rack
92-240-0001
2 Test Stations, Type ZT 222
230V/50Hz 12-252-0001 Spare Part Kit for Quick Clean basket rack
230V/60Hz 12-252-0002 92-240-0002
115V/60Hz 12-252-0003
127V/60Hz 12-252-0004 IQ/OQ/PQ documents for ZT 120/220/ 320
Disintegration Tester 65-2x0-9999
3 Test Stations, Type ZT 223
230V/50Hz 12-253-0001
230V/60Hz 12-253-0002 Special Versions
115V/60Hz 12-253-0003
127V/60Hz 12-253-0004 Disintegration Tester for testing the disintegra-
tion time of detergents. 70 1 strokes/min.
Delivery without disintegration baskets
4 Test Stations, Type ZT 224 12-251-1xxx
230V/50Hz 12-254-0001
230V/60Hz 12-254-0002
115V/60Hz 12-254-0003
127V/60Hz 12-254-0004

98
ERWEKA ZT 320 Series

The ERWEKA ZT 320 Series offers individual

operation of each test station. Each test-station
comes with its own function keypad and LE
display/s for individual programming of the test-
run time.
In standard configuration each test station of-
fers manual (optional automatic) lift-in and out
of the basket rack assembly on start/ comple-
tion of the pre-set run-time. An alarm can be
selected to be reminded. The actual bath tem-
perature is measured by an external electronic
PT 100 temperature sensor.
ZT 320 series disintegration testers (with op-
tional automatic lift-in/-out) at any time can be
upgraded for one, multiple or all test-stations.
1 to 4 test racks
30 1 strokes/min.
55 2 mm stroke height
LE display/s to show remaining run-time
and actual bath temperature
Optional automatic lift-in and -out of the
Basket Racks
Integrated flow-through heating system
(accuracy 0.2C)
RS 232 interface

1 Test Station, Type ZT 321 3 Test Stations, Type ZT 323

230V/50Hz 12-231-0001 230V/50Hz 12-233-0001
230V/60Hz 12-231-0002 230V/60Hz 12-233-0002
115V/60Hz 12-231-0003 115V/60Hz 12-233-0003
127V/60Hz 12-231-0004 127V/60Hz 12-233-0004

Automatic Lift-In and Out for ZT 321 Automatic Lift-In and Out for ZT 323
12-231-1xxx 12-233-1xxx

2 Test Stations, Type ZT 322 4 Test Stations, Type ZT 324

230V/50Hz 12-232-0001 230V/50Hz 12-234-0001
230V/60Hz 12-232-0002 230V/60Hz 12-234-0002
115V/60Hz 12-232-0003 115V/60Hz 12-234-0003
127V/60Hz 12-232-0004 127V/60Hz 12-234-0004

Automatic Lift-In and Out for ZT 322 Automatic Lift-In and Out for ZT 324
12-232-1xxx 12-234-1xxx

99
Options Upgrade
Automated lift-In and -out of the Basket Graphical display of the disintegration proc-
Rack Assembly/-ies on start/completion of ess of each individual sample.
the pre-set run-time of each test station.
This option guarantees that the disintegra- This addition to the [Link] software allows
tion of the samples cannot go on when the not only to determine the actual disintegra-
pre-set run-time is completed tion time but to show the size reduction of
the sample over the disintegration time.
Quick-Clean-Basket (100%
USP/EP/JP compliant) for Therefore this feature gives unique addi-
fast cleaning of the test sta- tional value to the normal disintegration test
tions. No tools required for since variations between the samples
disassembly and assembly. which later will have influence in the dissolu-
82-231-0006 tion result can be determined and re-
ported. 50-271-0001

Basket cleaning and media preheat station Computer package comprising of brand
(ZT 321/323 only) 11-23x-x1xx name PC, min. 17 TFT monitor, keypad,
mouse and colour printer; [Link] software
Basket Rack Assembly, Type B, with 3 pre-installed 50-270-0002
test-stations 82-240-0011

Basket Rack Assembly, Type B, with 3

test-stations in Quick-Clean version
82-240-0016

Water Stabiliser with colour indicator,

1 bottle 80-080-0002

USB Printer interface 12-23x-xx1x

IQ/OQ/PQ documents for ZT 120/220/ 320

Disintegration Tester 65-2x0-9999

Spares
Spare Part Kit for ERWEKA ZT 320 Series
92-230-0000

Spare Part Kit for basket rack

92-240-0001

Spare Part Kit for Quick Clean basket rack

92-240-0002

Spare Set (6) of glass tubes for Basket

Type A, standard 92-240-0061

Spare Set (3) of glass tubes for Basket

Type B, standard 92-240-0031

Spare Set (6) of disks for Basket Type A,

standard 92-240-0062

Spare Set (3) of disks for Basket Type B

92-240-0032

100
ERWEKA ZTm 320 Series Options
mBasket type B instead of type A
82-231-0000

mBasket type B (3 test-

stations)
82-231-3000

Disc Remover (Spider-Arm) for type A

The automated ZTm 320 disintegration tester 80-270-0001
series is based on the manual ZT 320 series
available with optional basket lift out feature; Computer package; incl. colour printer
but is also upgradable by one or more basket 50-271-0002
rack assemblies with automated detection, con-
trolled then via PC and the CFR 21/11 compli- Notebook, incl. TFT monitor, keypad, mouse
ant [Link] software package. and color printer - as well as software instal-
lation and test-run 50-271-0004
The ZTm allows the choice of manual and
automated test stations by mBasket (magnetic
guided disc and sieves both USP/EP compliant Spares
and sensors underneath the sieves) in type A
(6 test-stations) or type B (3 larger test sta- Spare-Part-Kit for mBasket (glass tubes,
tions) configuration. sieves and guides discs) 90-270-0002

The mBasket doesnt need any modification for Spare mBasket type A (6 test-stations)
measuring fully disintegrating and nonfully dis- 82-231-6000
integrating products such as film coated tablets,
gelatine capsules etc. The generated results
are then stored via the [Link] software package
(SQL server data base) and can be statistically
processed and printed at any time.

1 to 4 test racks
30 1 strokes/min.
55 2 mm stroke height
LE display/s to show remaining run-time
and actual bath temperature
Optional automatic lift-in and -out of the
Basket Racks
Integrated flow-through heating system
(accuracy 0.2C)
RS 232 interface

1 Test Station, Type ZTm 321 13-231-0000

2 Test Stations, Type ZTm 322 13-232-0000
3 Test Stations, Type ZTm 323 13-233-0000
4 Test Stations, Type ZTm 324 13-234-0000

101
ERWEKA PQ Tablets 90-240-0004
[Link] ruler for control
of stroke height

95-240-0004
[Link] ruler for control
of stroke height, num-
bered with certificate

95-270-0005
Set of 18 Distance
Plates: 0.6, 1.0 and 1.5
mm (6 plates per size),
certified

62-000-0006
1 Bottle (50) of ERWEKA PQ Tablets with
Distance plates of sizes 0.6mm, 1.0mm and 1.5
specified disintegration time to check the per-
mm (set of 9 with 3 plates per size) for special
formance of the unit, complete with certificate.
test basket (EP Application "B")
66-666-6665

Qualification tools for

Disintegration Testers
60-240-0000
Qualification
tool kit for ZT
120, ZT 220
and ZT 320
Series compris-
ing of stop
watch and
[Link] ruler

65-240-0000
Qualification tool kit for ZT 120, ZT 220 and
ZT 320 Series comprising of stop watch and
[Link] ruler with all tools in certified version

90-240-0003
Stop watch for control of
strokes/min.

95-240-0003
Stop watch for control of
strokes/min., certified

102
Tablet Friability-/ Abrasion Testers
ERWEKA TA Series ERWEKA TAR Series

Tablet Friability-/-Abrasion Testers of the TA Tablet Friability-/-Abrasion Tester with adjust-

Series comply 100% with all USP/EP require- able speed (20-100 rpm) and easy tablet insert.
ments. The drum is turned at 25 1 rpm, the On completion of the test run, the samples are
run-time can be adjusted by membrane function automatically removed from the drum.
keys in either time or turnings. The remaining Speed and run-time may be pre-set via the
run-time as well as the actual rpm are shown at membrane function keys. Nominal and actual
2 LE displays. speed as well as remaining run-time is shown
According to the latest specifications the unit is on the LE displays.
equipped with one additional switching leg to According to the latest specifications the unit is
bring the drum to the 10 position. equipped with one additional switching leg to
The optional USB interface allows you to either bring the drum to the 10 position for testing of
download the test parameters (time, actual/ bigger sized samples.
nominal speed) to a PC or receive hard-copy The optional USB interface allows you either to
printout when an optional printer is connected. download the test parameters (time, actual/
nominal speed) to a PC or receive a hard-copy
25 rpm printout when an optional printer is connected.
Available for 1, 2 or 4 drums
Compatible for ERWEKA friability- and 20 100 rpm
abrasion drums Available for 1 or 2 drums
DC frequency motor with constant actual/ Compatible with ERWEKA friability- and
nominal adjustment abrasion drums
Built-in timer DC frequency motor with constant actual/
Function membrane keys nominal adjustment for adjustable speed
2x LE display Built in timer
Switching leg for 10 adjustment Membrane function keys for pre-selection
of the test run-time in either number of
turns or time and rotation speed
2x LE display
Switching leg for 10 adjustment

TA 120 (for one drum, left) TAR 120 (for one drum, left)
100-240V/50-60Hz 12-310-0000 100-240V/50-60Hz 12-315-0000

TA 220 (for two drums, left and right) TAR 220 (for two drums, left and right)
100-240V/50-60Hz 12-320-0000 100-240V/50-60Hz 12-325-0000

Spare Part Kit (for TA 120/220 only) Spare Part Kit incl. 1 drum for TAR 120/220 only
92-310-0000 92-315-0000

TA 420 (for two double drums) TAR 420 (for two double drums)
100-240V/50-60Hz 14-340-0000 100-240V/50-60Hz 12-345-0000

Spare Part Kit incl. 1 drum 92-340-0000

Options for TA/TAR
USB interface 82-249-0000

103
ERWEKA TDR 100 Balances for Connection to TDR
Sartorius CPA 64
0.1 to 60.0 g, accuracy 0.1 mg. including
wind guard, integrated calibration weight,
RS 232 interface and interface cable to
ERWEKA TDR 70-330-0001

Sartorius CPA 64 OCE

Same as above, but gaugeable
75-330-0001

Mettler AB 54
0.1 to 50.0 g, accuracy 0.1 mg. including
The ERWEKA TDR 100 has been designed to wind guard, calibration weight, RS 232 in-
offer even more comfort as well as documenta- terface and interface cable to ERWEKA
tion. The TDR 100 is equipped with an interface TDR 70-330-0002
to connect either Mettler AB 54 or Sartorius CP
64 balances. The test procedure is completely
menu guided and test run parameters such as Options for TDR
rpm, weight before and after the test as well as
lost in percent is displayed (when a balance is Friability Drum with certificate
connected). To print out the documentation and 11-330-1xxx
results a printer can be connected to the printer
interface. Printer for docu-
mentation
One friability drum included in the delivery 71-249-0000
range
Easy load and automatic emptying of drum
(friability drum only)
Compatible for ERWEKA friability- and
abrasion drums
DC frequency motor with constant actual/
nominal adjustment for adjustable speed
Adjustable speed from 20 to 100 rpm
Built in timer
Numeric touch sensitive keys for pre-
selection of the test run-time in either
number of turns or time
Illuminated 4-line LC display
Printer interface for documentation of date,
time, test run parameters and results by a
connected printer
RS 232 serial interface for external control
and data transfer
Interface to connect Mettler or Sartorius
balance
Sample collection container

100240V/50Hz and 60Hz 11-330-0001

104
Friability Drums Abrasion Drums
Friability Drum, left for TA 120/220 Abrasion Drum, left for TA 120/
(not for automatic emptying) 220 (not for automatic empt.)
11-3x0-1xxx 11-3x0-3xxx

Friability Drum, left for TA 120/220, num- Abrasion Drum, left for TA 120/220, num-
bered with certificate of compliance (not for bered with certificate of compliance (not for
automatic emptying) 11-3x0-2xxx automatic emptying) 11-3x0-4xxx

Friability Drum, right for TA 220 (not for Abrasion Drum, right for TA 220 (not for
automatic emptying)1 1-320-x1xx automatic emptying) 11-320-x3xx

Friability Drum, right for TA 220, numbered Abrasion Drum, right for TA 220, numbered
with certificate of compliance (not for auto- with certificate of compliance (not for auto-
matic emptying) 11-320-x2xx matic emptying) 11-320-x4xx

Double Friability Drum, left for TA Double Abrasion Drum, left for TA
420, (not for automatic emptying) 420, (not for auto. empt.)
11-340-1xxx 11-340-3xxx

Double Friability Drum, left for TA 420, num- Double Abrasion Drum, left for TA 420,
bered with certificate of compliance (not for numbered with certificate of compliance (not
automatic emptying) 11-340-2xxx for automatic emptying) 11-340-4xxx

Double Friability Drum, right for TA 420, (not Double Abrasion Drum, right for TA 420,
for automatic emptying) 11-340-x1xx (not for automatic emptying) 11-340-x3xx

Double Friability Drum, right for TA 420, Double Abrasion Drum, right for TA 420,
numbered with certificate of compliance (not numbered with certificate of compliance (not
for automatic emptying) 11-340-x2xx for automatic emptying) 11-340-x4xx

Friability Drum, left for TAR Abrasion Drum, left for TAR 120/220, (not
120/220, with opening for auto- for automatic emptying) 11-3x5-3xxx
matic emptying 11-3x5-1xxx
Abrasion Drum, left for TAR 120/220, num-
Friability Drum, left for TAR 120/220, num- bered with certificate of compliance, (not for
bered with certificate of compliance, with automatic emptying) 11-3x5-4xxx
opening for automatic emptying
11-3x5-2xxx Abrasion Drum, right for TAR 220 (not for
automatic emptying) 11-325-x3xx
Friability Drum, right for TAR 220 with open-
ing for automatic emptying Abrasion Drum, right for TAR 220, num-
11-325-x1xx bered with certificate of compliance (not for
automatic emptying) 11-325-x4xx
Friability Drum, right for TAR 220, numbered
with certificate of compliance with opening
for automatic emptying
11-325-x2xx

105
IQ/OQ/PQ documents for ERWEKA PQ Tablets
Friability-Abrasion Testers
66-310-9999 IQ/OQ/PQ documents for
ERWEKA TA/TAR/TDR 100 se-
ries

IQ/OQ/PQ tools for Tablet

Friability-/ -Abrasion Testers
60-310-0000
Qualification tool kit for
TA, TAR and TDR Se-
ries, including of stop
watch, electronic rpm 1 Bottle (75) of ERWEKA PQ Tablets with
measuring tool and re- specified friability loss to check the performance
flector plates (35) of the unit, complete with certificate.
66-666-6666
65-310-0000
Qualification tool kit for TA, TAR and TDR
Series, certified

90-240-0003
Stop watch for control of
run-time

95-240-0003
Stop watch for control of
run-time, certified

70-310-0000
Electronic RPM measure-
ment unit, contactless;
including reflector marks
(35)

75-310-0000
Electronic RPM measurement unit, contact-
less, calibrated with certificate; including re-
flector marks (35)

106
ERWEKA GTA 120

ERWEKA friability tester type GTA 120 de- Operation procedure according Pharm.
signed for any form of tablets, granules and Eur. Vol.17, No.3, July 2005:
pellets according to the Pharm. Eur. Excellent
reproducibility is possible due to the precise a.) Before and after measurement the grau-
constancy of the input energy and due to the les/pellets have to be sieved through a 355
irrelevance of the tackiness of the test material sieve to remove any fines.
inside the glass bottle (test station). b.) 10.00 g of the sieved granules/pellets have
The single glass bottle is fixed to a holder which to be filled into the glass bottle, then the
is connected to an arm performing the shaking bottle is capped and fixed to the holder.
(oscillation) procedure as described in the c.) The test run has to be performed as men-
[Link]. An acrylic glass lid covers the test- tioned before.
ing area. The shaking intensity and duration are d.) The bottle is removed, opened and the
manually pre-selected. granules/pellets are again sieved through a
355 sieve in order to remove the fines.
Shaking frequency 0-400 strokes/min. e.) The weight of the sieved granules/pellets is
Run time 0-9999 seconds. measured again
Shaking angle 42. f.) The friability loss is calculated: m1 - m2
Test station complies with the regulations x100 m1
Security acrylic glass cover over the test g.) This procedure (a - f) has to be repeated 3
station times, then the average friability loss is
calculated.
100240V/50Hz and 60Hz 12-311-0001

Additional Test-Bottle 81-311-0001

IQ/OQ/PQ document for GTA 120 friability

tester 66-311-9999

107
Tablet Hardness Testers
ERWEKA TBH 125 Options
Diameter measurement; up to 28.00 mm;
resolution 0.01 mm; accuracy +/- 0.03 mm
12-422-1000

Thickness measurement; up to 28.00 mm;

resolution 0.01 mm; accuracy +/- 0.03 mm
12-422-1100

Integrated Printer for results, statistics and

calibration protocol 12-42x-xx1x

The TBH 125 is a basic dual-mode (Constant Extended measuring range; 10 500 N
Speed and Constant Force) tablet hardness 12-42x-1001
tester for those customers requiring accuracy
and robust design but very basic functions only. Spare part kit for ERWEKA TBH 125
The TBH 125 is operated via a symbol keypad 92-421-0000
which allows entering the number of samples
required for testing. Integrated Printer for results, statistics and
Results of sample hardness as well as sample calibration protocol 12-42x-xx1x
diameter (optional) are shown at the two bright
LED displays and can be printed (incl. Collection container with splash guard
date/time) via the standard USB printer inter- 80-421-0000
face.
Calibration is menu-guided and includes a cali- For Qualification (IQ/OQ) handbooks and
bration print-out (3-value linearity check) with Qualification/Calibration tools please see
date and time of performance as well as unit Qualification of tablet hardness testers
serial number.
Even at the TBH 125 the integrated menu al-
lows to set the measurement mode incl. break-
ing speed-/force increase rate, time/date, sensi-
tivity of the hardness measurement and a break
between the tests to remove dust and debris.

Up to 99 samples per test

Electronic load-cell
Tests samples up to 28 mm diameter
Measuring range 10 300 N;
Optional 10 500 N
Accuracy 1N
Adjustable break between the samples
Two measuring principles
Integrated programme menu for calibration
of the unit with documentation print out
USB Printer interface for documentation of
time, date, results and statistics

100-240V/50 and 60Hz 12-421-1000

108
ERWEKA TBH 225 ERWEKA TBH 225 D

The new TBH 225 series is the basic hardness Similar to the TBH 225, the ERWEKA TBH 225
tester developed for those customers who re- D offers the possibility to measure with the
quire robust design, easy handling and fast constant speed and constant force hardness
Qualification without fulfilling 21 CFR 11 regula- testing principle. The required measurement
tions. Since the samples are inserted into the principle may be selected by the programme
test station manually all kind and shapes of menu within seconds.
samples can be tested. In addition to the basic TBH 225 the TBH 225 D
The unit is handled by a block of numeric mem- measures and documents the sample diame-
brane keys and the menu displayed at the illu- ter/length. This also allows documenting that
minated full graphic LC display (240x64 dots). the sample was placed in the correct alignment
Calibration is completely menu guided and may for the hardness testing process.
be performed by either weight stones or the
electronic ERWEKA AutoCal System. Via a Measuring range for diameter:
standard USB printer interface a standard or up to 28.00 mm (D/28 Version)
laser printer (types on request) can be con- or optional
nected to receive hardcopy documentation. up to 70.00 mm (D/70 Version)
The LAN/USB interface allows connecting a Accuracy 1 N; 0.03 mm
computer with the optional [Link] software for Values in mm or inch
external control. In combination with this, the
TBH 225 series is 100% 21 CFR 11 compliant. 100-240V/50 and 60Hz 13-xx6-0xxx

Up to 99 samples per test

Electronic load-cell
Tests samples up to 28 mm diameter
Measuring range 10 500 N
Accuracy 1N
Adjustable break between the samples
Two measuring principles available as
standard
Turbo hardness test jaw, 3 times faster
than previous version
Integrated programme menu for calibration
of the unit with documentation print out
LAN/USB interface for external control and
storage of results by the optional [Link]
software
USB interface for USB memory stick stan-
dard
SD Card Slot standard
USB Printer interface for documentation of
time, date, results and statistics

100-240V/50 and 60Hz 13-425-0000

109
ERWEKA TBH 225 TD ERWEKA TBH 225 WTD

Similar to the TBH 225 the ERWEKA TBH 225 Semi-automated ERWEKA combination tester
TD offers the possibility to measure with the for testing the 4 essential parameters of round
constant speed and constant force hardness and odd shaped samples (weight, thickness,
testing principles. The programme menu may diameter and hardness). The TBH 225 WTD is
select the required measurement principle based on the TBH 225 TD and offers the same
within seconds. functions (constant speed and constant force
The TBH 225 TD in addition offers automatic measurement principle etc.).
measurement of sample diameter/length and In addition an external Sartorius or Mettler ana-
semi-automatic measurement of sample thick- lytical balance with windshield (20.0 mg to
ness. The units electronics are linked to a digi- 50.0000 g; accuracy 0.1 mg, Sartorius bal-
tal thickness measuring device under which the ance with in-built calibration weight) may be
sample is placed before testing hardness and connected to the unit. Before testing the other
diameter/length. The thickness measuring parameters, the sample is placed manually to
gauge is lowered manually and the displayed the balance; the weight is determined and
result is transferred to create either a 3 parame- transferred to the units electronics.
ter print-out or to transfer the data to a PC with
the optional [Link] software. Standard delivery range without balance; differ-
It is possible to select results in N, KP and SC ent brands and types of balances optionally
as well as mm and inch. available.

Additional features: Additional features:

Measuring range for diameter: up to 28.00 Measuring range for diameter: up to 28.00
mm (D/28 Version) mm
Measuring range for thickness: up to 12.00 Measuring range for thickness: up to 12.00
mm (T/12 Version) or optional up to 22.00 mm
mm (T/22 Version) Measuring range for weight (dependant on
Accuracy 1 N; 0.03 mm Type of balance): 20.0mg 50.0000g
Values in mm or inch Accuracy 1N; 0.03 mm; 0.1 mg
Values in mm or inch, mg or g

100-240V/50 and 60Hz 13-xx7-0xxx

100-240V/50 and 60 Hz W-/S 13-xx8-0xx5

110
Options
Sartorius CPA 64 balance incl. windshield
and integrated calibration weight for connec-
tion with TBH 225 WTD 13-xx8-0xx6

Sartorius CPA 64 OCE balance (gaugeable)

incl. windshield and integrated calibration
weight for connection with TBH 225 WTD
13-xx8-0xx7

Mettler AB 54 balance incl. windshield for

connection with TBH 225 WTD
13-xx8-0xx8

Extended Measuring Range, 3 - 1.000 N

12-44x-x1xx

Set of test jaws for testing of sugar coatings

80-430-0001

Test Jaws for Ob-

long Shaped Tab-
lets
80-430-0002

Measuring range for diameter: up to 70.00

mm (D/70 Version) 13-xx6-1xxx

AutoPosition tool not only aligns convex

shaped oblongs, additionally it moves the
tablets against the end point! Therefore the
risk of wrong measurement results by either
inaccurate manual positioning or turning of
the samples is dramatically lowered.
For testing of standard samples a standard
test-station, without rollers, is implemented.
Switching between the 2 different test-
stations is performed within seconds (no
tools required) 12-xxx-xx1x

Spare part kit for ERWEKA TBH 225

91-425-0000

For Qualification (IQ/OQ) documents and

Qualification/Calibration tools please see
Qualification of tablet hardness testers

111
Software Special Versions
ERWEKA [Link] Software Special version of ERWEKA TBH 225 for
testing of compressed detergents (TABS)
The ERWEKA [Link] software is directly con- 12-420-9xxx
nected with the serial LAN interface of the TBH
x25 and therefore allows PC operated external AutoCal 2.0 (Dynamic Calibration)
control of the Hardness-/Combination Tester as
well as online storage of user management, The new AutoCal 2.0 System is an auto-
product data, results as well as CFR 21/11 mated calibration tool for calibration of the
compliant Audit Trail. hardness test station without weights and
without the need of external PC and soft-
Due to the high memory capacity of the PC the ware. With the new AutoCal 2.0 the elec-
capacity of stored users, product data, results tronics-stick is plugged into the USB inter-
as well as CFR 21/11 Audit Trail is nearly face of the TBH x25 (previous series without
unlimited. USB interface require an adapter), the con-
nected certified load-cell inserted into the
Tolerances for test-results can be individually hardness test station. The complete system
set or automatically set according to USP or (adjustment and calibration) is now per-
[Link]. formed via the keypad and display of the
hardness tester, a report generated via the
An optional alarm function creates stop of the standard printer interface.
unit and alarm in case a sample is out of the set The unit will automatically adjust; calibration
pass/fail tolerance. In this case the user may can be checked by linearity checking of up
check why the measured result is out of the to 50 points within the measuring range and
pass/fail limit. documented by a connected printer.
85-450-0000
The CFR 21/11 compliant user management
allows individual definition of user groups, indi- Adaptor for connecting the AutoCal electron-
vidual user rights for each group including addi- ics stick to previous TBH series without USB
tional rights for individual users etc. Since, due interface 85-410-0000
to CFR 21/11 users can not be deleted from the
memory the [Link] software allows to switch For Qualification (IQ/OQ) documents and
users inactive and, on request, only to display Qualification/Calibration tools please see
active users. Qualification of tablet hardness testers.
Similar to users the [Link] software allows to
switch product data inactive and, on request,
only to display active product data.

The [Link] software is a tool to create various

statistical reports from the test-results, such as
test-run statistics, graphical batch statistics,
trend analysis etc.

The integrated CFR 21/11 compliant Audit Trail

tool of the [Link] software automatically stores
all Audit Trail data of the connected unit. The
Audit Trail data may be sorted according to
date or user/user group, displayed and printed
for hard-copy documentation.
50-420-0000

[Link] Software
Print software for hard-copy documentation at
any network printer when TBH is connected to
the computer Network via the LAN connector.
50-431-0000

112
ERWEKA TBH 225 Options
Industrial Version Diameter/length measurement for samples
with a diameter/length of up to 28.00 mm
The stainless steel, dust-protected Industrial (accuracy 0.03 mm), Version D/28;
Version of the TBH 225 series was developed 13-424-xx10
for those customers who require robust design,
easy handling and fast Qualification without Diameter/Length measurement for samples
fulfilling 21 CFR 11 regulations. Since the sam- with a diameter/length of up to 70.00 mm
ples are inserted into the test station manually (accuracy 0.03 mm), Version D/70;
all kind and shapes of samples can be tested. 13-424-1xx0
The unit is handled by a block of numeric mem- Hardness Tester with measuring range
brane keys and the menu displayed at the illu- 10 1000 N 13-424-x1x0
minated full graphic LC display (240x64 dots).
Calibration is completely menu guided and may Set of test jaws for testing of sugar coatings
be performed by either weight stones or the 80-430-0001
electronic ERWEKA AutoCal System.
Test Jaws for Ob-
Via a standard USB printer interface a standard long Shaped Tab-
or laser printer (types on request) can be con- lets
nected to receive hard copy documentation. 80-430-0002
The serial LAN/USB interface allows connecting
a computer with the optional [Link] software
for external control. In combination with this the AutoPosition tool not only aligns convex
TBH 225 series is 100% 21 CFR 11 compliant. shaped oblongs, additionally it moves the
tablets against the end point! Therefore the
Stainless steel, dust-protected housing risk of wrong measurement results by either
Up to 99 samples per test inaccurate manual positioning or turning of
Electronic load-cell the samples is dramatically lowered.
Tests samples up to 26/70 mm diameter For testing of standard samples a standard
Measuring range 10 500 N (optionally: test-station, without rollers, is implemented.
10 1000 N) Switching between the 2 different test-
Accuracy 1N stations is performed within seconds (no
Adjustable break between the samples tools required) 12-xxx-xx1x
Turbo hardness test jaw, 3 times faster
than previous version [Link] software (see TBH 225)
Two measuring principles available as 50-431-0000
standard
Integrated programme menu for calibration Spare part kit for ERWEKA TBH 225
of the unit with documentation print out 92-424-0000
LAN/USB interface for external control and
storage of results by the optional [Link]
software Other options from standard ERWEKA TBH
USB interface for USB memory stick stan- 225 Series (thickness- and weight meas-
dard urement, test-jaws etc.) are available on
SD Card Slot standard request.
USB printer interface for documentation of
time, date, results and statistics For Qualification (IQ/OQ) documents and
Qualification/Calibration tools please see
Qualification of tablet hardness testers
100-240V/50 and 60Hz 13-424-0000

113
ERWEKA TBH 325 ERWEKA TBH 325 D

The new TBH 325 series is the hardness tester Similar to the TBH 325, the ERWEKA TBH 325
with integrated product memory for up to 20 D offers the possibility to measure with the
products developed for those customers who constant speed and constant force hardness
require robust design, easy handling and fast testing principle. The required measurement
Qualification without complying 21 CFR 11 principle may be selected by the programme
regulations. menu within seconds.
Via the numeric membrane keypad with alpha- In addition to the basic TBH 325 the TBH 325 D
numeric sub function the nominal hardness in measures and documents the sample diame-
combination with 2 individual plus/minus toler- ter/length. This also allows you to document
ances and remarks may be stored for up to 20 that the sample was placed in the correct
different products and recalled for testing. In- alignment for the hardness testing process.
formation such as product name and remarks
can be entered similar to writing a message on
a mobile phone. Stored product data can be Additional features:
transmitted via SD card or USB stick to other
devices of the TBH 325/425 family. Since the Measuring range for diameter:
samples are inserted into the test station up to 28.00 mm (Version D/28) or op-
manually all kind and shapes of samples can be tional up to 70.00 mm (Version D/70)
tested. Calibration is completely menu guided Accuracy 1 N; 0.03 mm
and may be performed by either weight stones Values in mm or inch
or the dynamic ERWEKA AutoCal System.
Via a standard USB printer interface a printer
can be connected to receive hard copy docu- 100-240V/50 and 60Hz 13-xx6-0xxx
mentation. The serial LAN/USB interface allows
connecting a computer with the optional [Link]
software for external control. In combination
with this, the TBH 325 series is 100% 21 CFR
11 compliant.
Up to 99 samples per test
Electronic load-cell
Tests samples up to 28 mm or 70 mm di-
ameter
Measuring range 10 500 N, accuracy 1N
Adjustable break between the samples
Two measuring principles available as stan-
dard
Turbo hardness test jaw, 3 times faster
than previous version
Integrated programme menu for calibration
of the unit with documentation print out
LAN/USB interface for external control and
storage of results by the optional [Link]
software
USB interface for USB stick standard
SD Card Slot standard
USB Printer interface for documentation of
time, date, results and statistics
100-240V/50 and 60Hz 13-435-0000

114
ERWEKA TBH 325 TD ERWEKA TBH 325 WTD

Similar to the TBH 325 the ERWEKA TBH 325 Semi-automated ERWEKA combination tester
TD offers the possibility to measure with the for testing the 4 essential parameters of round
constant speed and constant force hardness and odd shaped samples (weight, thickness,
testing principles. The programme menu may diameter and hardness). The TBH 325 WTD is
select the required measurement principle based on the TBH 325 TD and offers the same
within seconds. functions (constant speed and constant force
The TBH 325 TD in addition offers automatic measurement principle etc.).
measurement of sample diameter/length and In addition an external Sartorius or Mettler ana-
semi-automatic measurement of sample thick- lytical balance with windshield (20.0 mg to
ness. The units electronics are linked to a digi- 50.0000 g; accuracy 0.1 mg, Sartorius bal-
tal thickness measuring device under which the ance with in-built calibration weight) is con-
sample is placed before testing hardness and nected to the unit. Before testing the other pa-
diameter/length. The thickness measuring rameters, the sample is placed manually to the
gauge is lowered manually and the displayed balance; the weight is determined and trans-
result is transferred to either create a 3 parame- ferred to the units electronics.
ter print-out or transfer the data to a PC with the
optional [Link] software. Standard delivery range without balance; differ-
It is possible to select results in N, KP and SC ent brands and types of balances optionally
as well as mm and inch. available.

Additional features: Additional features:

Measuring range for diameter: Measuring range for diameter: up to 28.00

up to 26.00 mm mm
Measuring range for thickness: Measuring range for thickness: up to 12.00
up to 12.00 mm mm
Accuracy 1 N; 0.03 mm Measuring range for weight (dependant on
Values in mm or inch balance): 20.0 mg 50.0000 g
Accuracy 1N; 0.03 mm; 0.1 mg
Values in mm or inch, mg or g
100-240V/50 and 60Hz 13-xx7-0xxx

100-240V/50 and 60Hz 13-xx8-0xx5

115
Options
Sartorius CPA 64 balance incl. windshield AutoPosition tool not only aligns convex
and integrated calibration weight for connec- shaped oblongs, additionally it moves the
tion with TBH 325 WTD 13-438-0006 tablets against the end point! Therefore the
risk of wrong measurement results by either
Sartorius CPA 64 OCE balance (gaugeable) inaccurate manual positioning or turning of
incl. windshield and integrated calibration the samples is dramatically lowered.
weight for connection with TBH 325 WTD For testing of standard samples a standard
13-438-0007 test-station, without rollers, is implemented.
Switching between the 2 different test-
Mettler AB 54 balance incl. windshield for stations is performed within seconds (no
connection with TBH 325 WTD tools required) 12-xxx-xx1x
13-xx8-0xx8
Spare part kit for ERWEKA TBH 325
Standard data export via LAN/USB interface 91-435-0000
82-44x-0002
For Qualification (IQ/OQ) documents and
Extended measuring range, 3 1.000 N, Qualification/Calibration tools please see
accuracy 1N 12-xxx-x1xx Qualification of tablet hardness testers

Enlarged of product memory from standard

20 products to up to 50 products AutoCal 2.0 (Dynamic Calibration)
82-4x0-0000
The new AutoCal 2.0 System is an auto-
Set of test jaws for mated calibration tool for calibration of the
testing sugar coatings hardness test station without weights and
80-430-0001 without the need of external PC and soft-
ware. With the new AutoCal 2.0 the elec-
tronics-stick is plugged into the USB inter-
Set of test jaws for face of the TBH x25 (previous series without
testing oblong shaped USB interface require an adapter), the con-
samples nected certified load-cell inserted into the
80-430-0002 hardness test station. The complete system
(adjustment and calibration) is now per-
formed via the keypad and display of the
Measuring range for diameter: up to hardness tester, a report generated via the
70.00 mm (Version D/70) 13-xx6-1xxx standard printer interface.
The unit will automatically adjust; calibration
can be checked by linearity checking of up
to 50 points within the measuring range and
documented by a connected printer.
85-450-0000

Adaptor for connecting the AutoCal electron-

ics stick to previous TBH series without USB
interface 85-410-0000

116
Software Packages [Link] software

ERWEKA [Link] Software Print software for hard-copy documentation

at any network printer when TBH is con-
The ERWEKA [Link] software is directly nected to the computer Network via the op-
connected with the serial LAN/USB inter- tional Ethernet (LAN) adapter
face of the TBH x25 and therefore allows 50-431-0000
PC operated external control of the Hard-
ness-/Combination Tester as well as online
storage of user management, product
data, results as well as CFR 21/11 compli-
ant Audit Trail.

Due to the high memory capacity of a PC

the capacity of stored users, product data,
results as well as CFR 21/11 Audit Trail is
nearly unlimited.

Tolerances for test-results can be individu-

ally set or automatically set according to
USP or [Link].

An optional alarm-function creates stop of

the unit and alarm in case a sample is out
of the set pass/fail tolerance. In this case
the user may check why the measured re-
sult is out of the pass/fail limit.

The CFR 21/11 compliant user manage-

ment allows individual definition of user
groups, individual user rights for each
group including additional rights for indi-
vidual users etc. Since, due to CFR 21/11
users can not be deleted from the memory
the [Link] software allows to switch users
inactive and, on request, only to display
active users.

Similar to users the [Link] software al-

lows to switch product data inactive and,
on request, only to display active product
data.

The [Link] software is a tool to create

various statistical reports from the test-
results, such as test-run statistics, graphi-
cal batch statistics, trend analysis etc.

The integrated LAN/USB compliant Audit

Trail tool of the [Link] software automati-
cally stores all Audit Trail data of the con-
nected unit.
The Audit Trail data may be sorted accord-
ing to date or user/user group, displayed
and printed for hard-copy documentation.

50-420-0000

117
ERWEKA TBH 425 ERWEKA TBH 425 D

Hardness Tester for automatic measurement of ERWEKA TBH 425 D is based on the TBH 425
up to 10 samples. Via the numeric membrane but in addition offers measurement and docu-
keypad with alpha-numeric sub function the mentation of the sample diameter/length.
nominal hardness in combination with 2 individ- This function allows verifying that the sample
ual plus/minus tolerances (T2 = pass/fail crite- was perfectly aligned before testing hardness.
ria) and remarks may be stored for up to 20
different products and recalled for testing. In-
formation such as product name and remarks
can be entered similar to writing a message on
a mobile phone. Stored product data can be
transmitted via SD card or USB stick to other
devices of the TBH 325/425 family. Calibration
is completely menu guided and may be per-
formed by either weight stones or the electronic
ERWEKA AutoCal System. Via a standard USB
printer interface a printer can be connected to
receive hardcopy documentation.
The serial LAN/USB interface allows connecting
a computer with the optional [Link] software
for external control. In combination with this, the
TBH 425 series is 100% 21 CFR 11 compliant.
Additional features:
10 chamber star feeder with brushes to
clean the transport way Measuring range for diameter: up to 28.00
Routine for alignment of oblong shaped mm
samples Accuracy 1 N; 0.03 mm
Tests samples up to 28 mm diameter Values in mm or inch
Measuring range 10 500 N, optional 10
1.000 N accuracy 1N 100V-240V/50Hz and 60Hz 13-xx6-xxxx
Values in N, Kp or Sc
Turbo hardness test jaw, 3 times faster
than previous version
Numeric keypad with alpha-numeric sub-
function for entry of test parameters, prod-
uct name, batch number and remarks
Integrated menu for calibration and ad-
justment with documentation print out
LAN/USB interface for external control and
storage of results by the optional [Link]
software
USB interface for USB stick standard
SD-Card Slot standard
USB printer interface for documentation of
time, date, results and statistics

100V-240V/50Hz and 60Hz 13-445-1000

118
ERWEKA TBH 425 TD ERWEKA TBH 425 WTD

The semi-automated TBH 425 TD in addition to The ERWEKA TBH 425 WTD is based on the
the standard TBH 425 offers automatic meas- TBH 425 TD.
urement of sample diameter/length and thick- In addition an external Sartorius or Mettler ana-
ness by a motor-driven and calibratable elec- lytical balance with windshield (20.0 mg to
tronic linear potentiometer. The unit can either 50.0000 g; accuracy 0.1 mg; Sartorius bal-
fulfil a 3 parameter hard-copy print-out by a ance with in-built calibration weight) may be
connected printer (optional) or transfer the data connected to the unit. Before testing the other
to a PC with the optional [Link] software. parameters, the sample is placed manually onto
the balance, the weight is determined and
transferred to the units electronics.

Standard delivery range without balance; differ-

ent brands and types of balances optionally
available.

Additional features:
Additional features:
Automatic measurement of hardness,
thickness and diameter/length Measuring range for weight (dependant on
Measuring range for thickness: up to 10.00 balance): 20.0 mg 50.0000 g
mm Accuracy 1N; 0.03 mm; 0.1 mg
Accuracy 1 N; 0.03 mm Values in mm or inch, mg or g
Values in mm or inch
100V-240V/50Hz and 60Hz 13-xx8-xxx5
100V-240V/50Hz and 60Hz 13-xx7-xxxx

119
Options AutoCal 2.0 (Dynamic Calibration)
Sartorius CPA 64 balance incl. windshield The new AutoCal 2.0 System is an auto-
and integrated calibration weight for connec- mated calibration tool for calibration of the
tion with TBH 425 WTD hardness test station without weights and
13-xx8-0xx6 without the need of external PC and soft-
ware. With the new AutoCal 2.0 the elec-
Sartorius CPA 64 OCE balance (gaugeable) tronics-stick is plugged into the USB inter-
incl. windshield and integrated calibration face of the TBH x25 (previous series without
weight for connection with TBH 425 WTD USB interface require an adapter), the con-
13-xx8-0xx7 nected certified load-cell inserted into the
hardness test station. The complete system
Mettler AB 54 balance incl. windshield for (adjustment and calibration) is now per-
connection with TBH 425 WTD formed via the keypad and display of the
13-xx8-0xx8 hardness tester, a report generated via the
standard printer interface.
Standard data export via LAN/USB interface The unit will automatically adjust; calibration
82-44x-0002 can be checked by linearity checking of up
to 50 points within the measuring range and
Groove in the hardness test station for better documented by a connected printer.
alignment of oblong shaped samples 85-450-0000
12-44x-1xxx
Adaptor for connecting the AutoCal electron-
Stainless steel magazine plate ics stick to previous TBH series without USB
12-44x-xxx1 interface 85-410-0000

Extended measuring range, 10 1.000 N, Spare part kit for ERWEKA TBH 425
accuracy 1N 12-44x-x1xx 92-450-0000

Increase of product memory from standard

20 products to up to 50 products
82-4x0-0000 Special Versions
Set of test jaws for 12-44x-xx1x Special version of ERWEKA
testing of sugar coat- TBH 425 with 20 chambers,
ings [Link] feeder and transport-
80-430-0001 way for testing fertilisers.

12-44x-xx2x Special version of ERWEKA

TBH 425 with 30 chambers,
Set of test jaws for [Link] feeder and transport-
testing oblong shaped way, including readjustment of
samples moveable jaws, calibration ad-
80-430-0002 justment and software modifica-
tion.

For Qualification (IQ/OQ) documents and

Qualification/Calibration tools please see
Qualification of tablet hardness testers.

120
ERWEKA TBH 525
such as product name and remarks can be
entered similar to writing a message on a mo-
bile phone.

Stored product data can be transmitted via SD

card or USB stick to other devices of the TBH
325/425 family.

Cleaning of the unit is fast and easy: the maga-

zine is to be removed so the complete transport
way with all test stations to offer easy access to
the transport way and all test station for manual
cleaning.
Semi automated tablet combination tester for
measuring up to 5 parameters (weight, thick- Calibration is completely menu guided and may
ness, width, diameter/length and hardness) of be performed by either weight stones or the
round and oblong shaped samples. electronic ERWEKA AutoCal 2.0 System.

The TBH 525, in standard configuration, comes Via a standard USB interface a printer can be
with a 20 position magazine to hold samples up connected to receive hardcopy documentation.
to maximum diameter/length of 26 mm. The Alternatively the TBH 525, similar to TBH
integrated menu allows setting an individual 225/325/425, via LAN interface, can be inte-
number of tablets to test for each parameter, grated into computer network to allow hard
e.g. 20 for weight, 15 for thickness, 10 for width, copy documentation at a central network printer
diameter/length and hardness. ([Link] software required).

By an integrated load cell the TBH 525 WTD The serial LAN/USB interface allows connecting
measures the weight with a tolerance of 0.1 a computer with the optional [Link] software
mg. The test station is designed in such way for external control. In combination with this, the
that always the complete sample will lay on the TBH 525 series is 100% 21 CFR 11 compliant.
weight measurement plate. 20 chamber star feeder
integrated weighing system
Thickness measurement is performed by a low weight precision thickness measure-
device which assures that a minimum of ment device
weight/force is introduced to the sample to Unique roller alignment system to position
guarantee precise measurement even of soft oblong shaped samples
and elastic tablets. Tests samples up to 26 mm diameter
Measuring range 3 400 N, optional 3
The hardness test station is equipped with a
800 N accuracy 1N
unique roller-alignment-system:
Values in N, Kp or Sc / mm or inches / g or
1. The sample is inserted into the test station in
mg
such way that the width is measured by the
Numeric keypad with alpha-numeric sub-
test-jaw
function for entry of test parameters, prod-
2. The roller system will then turn the oblong
uct name, batch number and remarks
so the length and hardness can be correctly
Integrated menu for calibration and ad-
measured
justment with documentation print out
3. After measurement the rollers will move
LAN/USB interface for external control and
back so the broken sample, together with
storage of results by the optional [Link]
the dust and debris, is rejected
software
The design of the test jaw allows that even
USB interface for USB stick standard
small samples in combination with the roller
SD-Card Slot standard
system can be precisely measured for hard-
USB printer interface for documentation of
ness.
time, date, results and statistics
Via the numeric membrane keypad with alpha-
numeric sub function the nominal hardness in 100V-240V/50Hz and 60Hz 14-445-0000
combination with 2 individual plus/minus toler-
ances (T2 = pass/fail criteria) and remarks may
be stored for up to 20 (optional 50) different
products and recalled for testing. Information

121
Options group including additional rights for indi-
vidual users etc. Since, due to CFR 21/11
Diameter/Width Measurement (measuring users can not be deleted from the memory
range 0.10 to 26.00 mm with an accuracy the [Link] software allows to switch users
of +/- 0.03 mm) 14-xx6-xxxx inactive and, on request, only to display
active users.
Thickness Measurement (measuring range
0.10 to 12.00 mm with an accuracy of +/- Similar to users the [Link] software al-
0.03 mm) 14-xx7-xxxx lows to switch product data inactive and,
on request, only to display active product
Weight Measurement, integrated, incl. data.
Sartorius weighing cell 14-xx8-xxx5
The [Link] software is a tool to create
Extended Measuring Range, 800 N various statistical reports from the test-
12-45x-x1xx results, such as test-run statistics, graphi-
cal batch statistics, trend analysis etc.
Increase of product memory from standard
20 products up to 50 products The integrated CFR 21/11 compliant Audit
82-4x0-0000 Trail tool of the [Link] software automati-
cally stores all Audit Trail data of the con-
Spare Part Kit for TBH 525 nected unit.
92-450-0000 The Audit Trail data may be sorted accord-
ing to date or user/user group, displayed
and printed for hard-copy documentation.
50-420-0000

Software Packages [Link] Software

ERWEKA [Link] Software Print software for hard-copy documentation

at any network printer when TBH is con-
ERWEKA [Link] software is directly con- nected to the computer Network via the
nected via the serial interface with TBH LAN connector 50-431-0000
x25 and therefore allows PC operated ex-
ternal control of the Hardness-
/Combination Tester as well as online stor- For Qualification (IQ/OQ/PQ) documents and
age of user management, product data, Qualification/Calibration tools please see
results as well as CFR 21/11 compliant Qualification of tablet hardness testers.
Audit Trail.

Due to the high memory capacity of a PC

the capacity of stored users, product data,
results as well as CFR 21/11 Audit Trail is
nearly unlimited.

Tolerances for test-results can be individu-

ally set or automatically set according to
USP or [Link].

An optional alarm-function creates stop of

the unit and alarm in case a sample is out
of the set pass/fail tolerance. In this case
the user may check why the measured re-
sult is out of the pass/fail limit.

The CFR 21/11 compliant user manage-

ment allows individual definition of user
groups, individual user rights for each

122
 Function:
ERWEKA MultiCheck 5.1 The samples are individualised automatically by
a new system for separation of the samples via
an oscillating funnel and then deposited onto
the weight measurement boat. From there the
samples are transported to the test stations by
a linear feeder which allows alignment of ob-
longs as well as odd shaped samples such as
sugar coatings. In case of problematic samples
a down holder in the hardness test station is
available as an option. A patented step in the
transport way allows you to switch tablets which
tend to lie on the side.

The unit is controlled by an optional external

PC.
The ERWEKA MultiCheck 5.1 is a universal
testing device for fully automatic measurement
Software Package [Link] (included):
of sample weight, thickness, diameter/length
ERWEKA [Link] software is directly connected
and hardness.
via Ethernet network connection with the Multi-
Check 5.1. The Software allows PC operated
The advanced design of the unit, beginning
external control of the Hardness-/Combination
even from the outside, shows the innovative
Tester as well as online storage of user man-
functions such as switchable hardness testing
agement, product data, results as well as CFR
principle (Constant-Speed and Constant-
21/11 compliant Audit Trail.
Force), fully automatic speed adjustment of
tablet singulation and transport, independent of Due to the high memory capacity of a PC the
sample size and surface, advanced high- capacity of stored users, product data, results
accuracy thickness measuring system and as well as CFR 21/11 Audit Trail is nearly
state-of-the-art alignment tool for irregular unlimited.
shaped oblongs and coated tablets.
Tolerances for test-results can be individually
set or automatically set according to USP or
The new MultiCheck 5.1. comes with a system
[Link].
for separation of the samples via an oscillating
funnel. This system eliminates the need of vi- An optional alarm-function creates stop of the
brator strength adjustment as previously neces- unit and alarm in case a sample is out of the set
sary for the other MultiCheck versions. pass/fail tolerance. In this case the user may
check why the measured result is out of the
In standard configuration the MultiCheck 5.1 pass/fail limit.
offers an integrated Sartorius weighing cell
(accuracy +/- 0.1 mg). On request the new unit The CFR 21/11 compliant user management
is also available with Sartorius CPA 64 (with allows individual definition of user groups, indi-
integrated display) or CPA 64 OCE (gaugeable vidual user rights for each group including addi-
version with integrated display, accuracy +/- tional rights for individual users etc.
0.01 mg). Similar to users the [Link] software allows to
switch product data inactive and, on request,
Further the MultiCheck 5.1 can be fitted with an only to display active product data. The [Link]
overworked alignment flap, a tool which allows software is a tool to create various statistical
aligning and holding oblongs in the correct posi- reports from the test-results, such as test-run
tion for and while breaking. At the version 5.1 statistics, graphical batch statistics, trend
the alignment flap (down-holder) is modernized analysis etc.
in such a way that now it creates more force to
hold the samples while the breaking process. The integrated CFR 21/11 compliant Audit Trail
tool of the [Link] software automatically stores
The MultiCheck 5.1 in combination with the all Audit Trail data of the connected unit.
ERWEKA TabSelect flap/switch and the Venturi The Audit Trail data may be sorted according to
air transport system can be connected to any date or user/user group, displayed and printed
single or double sided tablet press. for hardcopy documentation.

123
Important Information
- The area in front of the hardness and under Measuring range 3 500 N, optional 3
the width measurement station should be 1.000 N, thickness up to 12.0 mm
always dust-free and free of damage. We Accuracy 1N, 0.03 mm and 0.1 mg
recommend scheduled service (approxi- In combination with the Sartorius weighing
mately every 300 operating hours) from an cell the MultiCheck 5.1 offers an accuracy of
ERWEKA service engineer or qualified per- +/- 0.1mg, in combination with the CPA 64
sonnel OCE (gaugeable) the accuracy is even 10
times higher (+/- 0.01mg)
- We recommend pre-adjustment with PQ Ethernet network connection of the unit
tablets in our service department

- The option width measurement should be

always offered with the option down holder Price includes:
1. MultiCheck 5.1 as described
- Extended measuring range up to 35mm in 2. Software package [Link]
combination with width measurement is
available on request !!! Excluding PC !!!

MultiCheck 5.1 (manual operation of hood) -

Fully automated measurement of weight,
hardness, thickness and diameter / length of
round and oddly shaped samples, including
Sartorius weighing cell and [Link] Soft-
ware.

100V-240V/50Hz and 60Hz 14-455-0000

MultiCheck 5.1 (manual operation of hood) -

Singulation of samples via an oscillating Fully automated measurement of weight,
funnel hardness, thickness and diameter / length of
Possibility of optical length and width meas- round and oddly shaped samples. Sartorius
urement of oblong shaped samples meas- weighing cell. Incl. 12 chamber batch feed-
ured within the hardness test station. Utiliz- ing magazine for up to 100 samples per
ing a laser the width is automatically an ac- chamber and [Link] software.
curacy of +/- 0.1 mm prior to length and
hardness measurement. The results are 100V-240V/50Hz and 60Hz 14-456-0000
then displayed, stored and documented.
Fully automatic measurement of weight,
hardness, thickness and diameter/length of
round and oddly shaped samples
Optional batch feeding magazine with 12-
chambers for up to 100 samples/ chamber
Weight measurement boat to eliminate the
problems caused by dust and debris
Linear transport of the samples to align ob-
longs
Automatic cleaning of transport way and test
jaw
Optional down holder for alignment of prob-
lematic samples
Test samples up to 26 mm diameter, op-
tional up to 35 mm

124
Options PC in ERWEKA standard configuration
(brand name PC in minitower housing, CPU
Down Holder for alignment of difficult to Intel Pentium Dual Core 2 Duo with mini-
position samples including one universal mum 2.6GHz, Hard disk with minimum 250
down holding tool for oblong shaped tablets. GB, Main Memory with minimum 2048 MB, 3
serial interfaces, 6 USB 2.0 interfaces, 16x
80-455-0000 DVD-ROM device, Windows XP, keyboard,
scroll mouse and 19'' flat screen TFT moni-
Electronically adjustable step before the tor) 80-430-0009
thickness measurement station to drop
samples to the right side 2x-45x-xx1x Spare Part Kit for MultiCheck 5.1, including
fuses, initiator, toothed belt and reflex button
Housing made of 94-070-0001
stainless steel
82-455-0001

AutoCal 2.0 (Dynamic Calibration)

Picture shows MultiCheck V The new AutoCal 2.0 System is an auto-
mated calibration tool for calibration of the
Additional price Sartoruis Balance with dis- hardness test station without weights and
play instead Sartorius weighing cell without the need of external PC and soft-
82-455-9001 ware. With the new AutoCal 2.0 the elec-
tronics-stick is plugged into the USB inter-
Additional price gaugeable balance, type face of the TBH x25 (previous series without
Sartorius CPA 64 OCE instead of standard USB interface require an adapter), the con-
weighing cell 82-455-9000 nected certified load-cell inserted into the
hardness test station. The complete system
Extended measuring range of up to 35mm (adjustment and calibration) is now per-
diameter 1x-45x-1xxx formed via the keypad and display of the
hardness tester, a report generated via the
Width Measurement for oblongs (up to standard printer interface.
10mm; accuracy: +/- 0,1mm) The unit will automatically adjust; calibration
82-455-0002 can be checked by linearity checking of up
to 50 points within the measuring range and
Capsule system (weight determination) documented by a connected printer.
1x-45x-xxx1 85-450-0000
Measurement of capsule length (optical)
1x-45x-2xxx AutoCal re-calibration with calibration certifi-
cate 36-441-0010
Extended measuring range (3-1.000 N) with
1N accuracy; test-speed up to 2.30
mm/sec. 1x-45x-x1xx

ERWEKA [Link] Software for the external

control of the MC 5.1 system and the online
storage of user management data, measur-
ing results as well as CFR21/11 compliant
audit trail data 50-420-0000

125
Tablet Press Connection Calibration/Qualification tools
for diameter and thickness
82-455-0001 TabSelect (for the connection
of tablet press with MC 5.1) measuring station
80-421-0010
80-455-0002 Venturi Transport System,
1.0 mm block, [Link]
VTS-1, with interface
85-421-0010
80-455-0003 AutoDoc Control Software 1.0 mm block, [Link]
package, instead [Link] soft- with certificate
ware
L 80-421-0030
3.0 mm block, [Link]
IQ/OQ/PQ documents for Tablet
85-421-0030
Hardness Testers 3.0 mm block, [Link] with certificate
63-425-9999 IQ/OQ/PQ documents for 80-421-0050
ERWEKA TBH 225/325/425/ 5.0 mm block, [Link]
525 series in English language
85-421-0050
83-425-9999 IQ/OQ/PQ documents for 5.0 mm block, [Link] with certificate
ERWEKA TBH 255/355/455/
525 series in another language 80-421-0100
10.0 mm block, [Link]
67-455-9999 IQ/OQ/PQ documents for
ERWEKA MultiCheck 5.1 and 85-421-0100
[Link] software 10.0 mm block, [Link] with certificate

Calibration/Qualification tools
IQ/OQ/PQ tools for Tablet
for weight measuring station
Hardness Testers
85-423-0050
80-440-0002 Calibration weight 50.0 g, class F1, calibrated
Qualification Tablets for MultiCheck, plastics with certificate
85-440-0002 85-423-0100
Qualification Tablets for MultiCheck, plastic, 100 mg weight,
numbered with certificate Class F1, cali-
brated with cer-
80-440-0003 tificate
Qualification tablets
for MultiCheck, 85-423-0500
[Link] 500 mg weight, class F1, calibrated with certifi-
cate
85-440-0003 85-423-0001
Qualification tablets for MultiCheck, [Link], 1.0 g weight, class F1, calibrated with certificate
laser numbered with certificate

126
Hardness Test Station ERWEKA PQ Tablets
Static Calibration Tools
80-420-0500
Calibration weight, 5.0 kg, class M3

85-420-0500
Calibration weight, 5.0 kg, class M1, calibrated
with certificate

80-420-1000
Calibration weight, 10.0 kg, class M3

85-420-1000
Calibration weight, 10.0 kg, class M1, cali-
brated with certificate
1 Bottle (75) of ERWEKA PQ Tablets with
specified weight, hardness, diameter and
80-420-2000
thickness to check the performance of the
Calibration weight, 20.0 kg, class M3
unit, complete with documentation.
66-666-6666
85-420-2000
Calibration weight, 20.0 kg, class M1, calibrated
with certificate

Hardness Test Station,

Dynamic Calibration Tool
The new AutoCal 2.0 System is an auto-
mated calibration tool for calibration of the
hardness test station without weights. With
an upgraded load cell, now a calibration of a
Hardness Tester without interface box is
possible. The load cell is connected directly
to the device via USB-stick, therefore elimi-
nating connection to a PC. For older models
of the TBH x10 series an adapter is avail-
able. To simplify the input of the alpha nu-
meric data, now an external IBM keypad can
be connected to the TBH 325/425 for enter-
ing the master product data, batch numbers
etc.
The unit will automatically adjust; calibration
can be checked by linearity checking of up
to 50 points within the measuring range and
documented by a connected printer. Includ-
ing Windows based Calibration Software

127
Modular Check Weighing Systems
ERWEKA CWS Options for ERWEKA CWS
Three diversion flaps to sort the samples of
1 batch according to the entered tolerances
(pass/fail or up to 3 individual tolerances)
10-41x-1xxx

CWS Check Weighing System with 10

chamber storage magazine for 10 batches of
up to 100 samples per chamber or 1 batch
of up to 1.000 samples (10x100), including
upgraded programme menu
10-411-0000

CWS Check Weighing System with 10

chamber diversion system to sort the tested
samples according to the chambers of the
storage magazine (including 10 chamber
storage magazine, 10-411-xxxx, not avail-
able with diversion flap 10-41x-1xxx and 10-
The ERWEKA CWS acts as the base of all 412-0000) 10-411-0001
ERWEKA Check Weighing Systems.
Up to 50 samples can be loaded. The unit will CWS Check Weigh-
automatically individualise the samples and ing System with
transport them to the balance boat. The weight 10x2 chamber di-
is determined by a Sartorius CPA 64 balance. version system to
When the weight is stable, the sam-ple will be sort the tested sam-
transported into a container. ples according to
The unit is operated by an alpha-numeric touch- the chambers of the
sensitive keypad and a full-graphic backlit LC storage magazine
display. Results can be displayed, hard copied and individual
via the parallel printer port or be transferred to a pass/fail criteria
computer by the standard RS 232 serial inter- (including 10 chamber storage magazine,
face. 10-411-1xxx and diversion flaps 10-411-
0000) 10-412-0000
Weight measurement boat to eliminate the
problems caused by dust and debris CWS Check Weighing System with Storage
Optional diversion unit according to products and individualising container for up to
and/or tolerances 10.000 samples. 10-415-0000
Measuring range 20 mg to 20 g
Throughput max. 20 samples/min. at accu- Ethernet (LAN) Network Connection adapter
racy +/- 0.5 mg (standard) or optional max. 80-430-0003
12 samples/min. at accuracy +/- 0.1 mg
(please specify) USB printer interface adapter for standard
Product memory for up to 49 products to parallel printer port (PCL) 80-270-0000
store nominal values, 3 tolerances and re-
marks under product name and -number
Integrated programme menu for calibration Software
of the unit with documentation print-out
RS 232 and RS 485 serial interface for ex- ERWEKA CFR 21/11 compliant [Link]
ternal control and storage of results by the Windows based Software for external control
optional ERWEKA CWS software and to store the results of the tests as well
Parallel printer interface for documenta-tion as batch comparison and to lay down prod-
of time, date, results and statistics uct data incl. tolerances
50.0 g weight, class F1 for calibration of the 50-410-0000
weight measuring station

100-240V/50 and 60Hz 10-410-0000

128
IQ/OQ/PQ Documents for Check
Weighing System, Type CWS
66-410-9999 IQ/OQ/PQ documents for
ERWEKA CWS

Calibration/Qualification tools for

weight measuring station

85-423-0050
Calibration weight 50.0 g, class F1, calibrated
with certificate

85-423-0100
100 mg weight, class F1, calibrated with certifi-
cate

85-423-0500
500 mg weight, class F1, calibrated with certifi-
cate

85-423-0001
1.0 g weight, class F1, calibrated with certificate

ERWEKA PQ Tablets

1 Bottle (75) of ERWEKA PQ tablets with speci-

fied weight to check the performance of the
unit, complete with documentation
66-666-6666

129
Powder and Granulate Testers Bulk Density

ERWEKA GTL ERWEKA GT

The ERWEKA GTL is the basic ERWEKA unit The ERWEKA GT has been designed to offer
for testing the flow characteristics of powders either measurement of flow time according to
and granulates. It is equipped with an ex- specified amount (weight or volume) or amount
changeable stainless steel hopper (200 ml) with (weight) according to specified time. It is
exchangeable outlet nozzle (3 sizes of nozzles equipped with an exchangeable stainless steel
standard: 10.0, 15.0 and 25.0 mm; 3 different hopper (480 ml) and exchangeable out-let noz-
sizes optional). The pre-weighed sample is zle (3 sizes of nozzles standard: 10.0, 15.0 and
filled into the hopper and a light sensor located 25.0 mm; 3 different sizes optional) as well as a
under the outlet of the hopper measures the balance located under the outlet of the hopper.
flow time. The product data is entered via the alpha-
When determination of flow time of the sample numeric keypad, results are shown on the illu-
volume is requested, two additional stainless minated 320 digit full-graphic LC display and
steel hoppers with different volumes are avail- can be printed out using the standard parallel
able as an option. printer interface or transferred to a PC via the
The unit is controlled via the numeric mem- standard RS 232 interface.
brane keypad, results are shown by the illumi-
nated 4-line LC display. 100-240V/50-60 Hz 10-451-0000

100-240V/50-60 Hz 11-450-0000 Options

Options When testing the characteristics of products
with poor flow the unit can be equipped with
Set of 3 outlet nozzles with outlet diameter a stirrer in the hopper 10-451-1xxx
6.0, 8.0 and 11.3 mm, stainless steel
80-450-0003 Set of 3 outlet nozzles
with outlet diameter
Stainless steel hopper, 6.0, 8.0 and 11.3
480 ml volume mm), stainless steel
80-450-0480 80-450-0003

Stainless steel hopper, 100 ml volume

80-450-0100
Stainless steel hopper, 100 ml volume Stainless steel hopper, 200 ml volume
80-450-0100 80-450-0200

USB printer interface adapter for standard

parallel printer port (PCL)
80-270-0000

Standard data export via RS232 interface

for GT 82-44x-0001

130
ERWEKA GTB ERWEKA SMG

The manual ERWEKA SMG is the unit for the

reproducible determination of apparent (bulk)
density which can be used with all free flowing
powders or granules. According to DIN ISO 697
The ERWEKA Flow ability Tester, Type GTB is
and DIN 53 466, the apparent density is deter-
based on the GT but also measures and docu-
mined by measuring the mass of powder in a
ments the angle of repose optically (by laser).
receiver of known dimension after filling from a
funnel of a specified shape under specified
100-240V/50-60 Hz 10-452-0000
conditions. Within the scope of supply are the
apparatus SMG 697 or SMG 53466, operating
instructions and a calibration certificate.
Spare Part Kit for GTB 92-457-0000
SMG 53 466 SMG 697
Height: 205 mm 280 mm
Options Width : 156 mm 210 mm
Depth: 156 mm 147 mm
When testing the characteristics of pow- Weight: 4.6 kg 7,5 kg
ders or granulates with poor flow the Material: 1.4305/1.4571 1.4305/1.4571
ERWEKA GTB can be equipped with a Receiver: 100 ml 500 ml
stirrer in the hopper 10-452-1xxx 71-455-2001 71-455-1001

Set of 3 outlet nozzles with outlet diameter IQ/OQ/PQ documents for

6.0, 8.0 and 11.3 mm, stainless steel
80-450-0003 Granulate-Flow Testers
66-450-9999 IQ/OQ/PQ documents for
Stainless steel hopper, 100 ml volume ERWEKA GTL; GT; GTB
80-450-0100

Stainless steel hopper, 200 ml volume Qualification tools for GT/B Series
80-450-0200
60-451-9999
USB printer interface adapter for standard Qualification tool kit for GTL (including stop
parallel printer port (PCL) watch)
80-270-0000
66-451-9999
Standard data export via RS232 interface Qualification Tool Kit for GT comprising of stop
for GTB 82-44x-0001 watch and weights for balance

66-452-9999
Qualification Tool Kit
for GTB comprising
of 66-451-9999 plus
special cones for
laser Qualification

85-451-0000
Calibration weights (2x 2.0 kg) for readjust-
ment of the integrated balance (GT and GTB
only)

131
Powder & Granulate Testers Tapped Density
ERWEKA SVM 121 and 221 ERWEKA SVM 122 and 222

The ERWEKA SVM 121 (one test station) and ERWEKA Tapped Density Testers, Type SVM
SVM 221 (two test stations) meet the specifi- 122 and SVM 222 are equal to SVM 121 and
cations of USP apparatus 1 (stroke height 221 but designed to meet the specifications of
15 mm, 300 strokes per minute tapped metal on USP apparatus 2, [Link]. and DIN ISO EN
metal). The test run duration can be adjusted 787, part 11 (stroke height 3.0 mm, 250 15
either in time or strokes (up to 99.999) by strokes per minute).
membrane function keys. The remaining test
run-time as well as actual stroke are shown on
the illuminated 2 LE displays (the standard unit
is delivered without glass-ware).

SVM 121 (one test station) SVM 122 (one test station)
100-240V/50-60 Hz 12-453-1000 230V/50Hz 12-454-1001
230V/60Hz 12-454-1002
115V/60Hz 12-454-1003
SVM 221 (two test stations) 127V/60Hz 12-454-1004
100-240V/50-60 Hz 12-453-2000

SVM 222 (two test stations)

100-240V/50-60 Hz 12-454-2000

132
ERWEKA SVM 223 Glassware for SVM Series
(only two test stations) All ERWEKA Glass Cylinders are with adaptor
kit according to USP or EP

Glass Cylinder, 100 ml

80-453-0100

Glass Cylinder, 250 ml

80-453-0250

Glass Cylinder, 500 ml includ-

ing conversion plate for holder
of SVM Series
80-453-0500

IQ/OQ/PQ documents Tapped

ERWEKA Tapped Density Testers, Type SVM Density Testers
223 combines the two different specifications in
only one unit. Test station 1 operates according IQ/OQ/PQ document for ERWEKA SVM
to USP apparatus 1, test-station 2 at the same 66-453-9999
time according to USP apparatus 2/ EP/DIN
ISO EN 787, part 11. The test run-time can be
chosen only in time (not in strokes). Qualification tool kits for SVM
Series
100-240V/50Hz 12-455-2000
Qualification tool kit for ERWEKA SVM Se-
ries comprising of stroke height checker and
digital stopwatch 60-453-0001
Spare Part Kit vor SVM 91-456-000
Qualification tool kit for ERWEKA SVM Se-
ries comprising of stroke height checker and
digital stop watch, certified 65-453-0001

Options
USB printer interface adapter for standard
parallel printer port (PCL) 80-270-0000

133
Suppository Testers
ERWEKA Suppository ERWEKA Circulation
Hardness Tester, Type SBT 2 Heater, EST 2

230V/50Hz 10-466-5001
Suppository Hardness Tester comprising of an 230V/60Hz 10-466-5002
electrical heated chamber with a number of 115V/60Hz 10-466-5003
inserts to accept various size of suppositories. 127V/60Hz 10-466-5004
The hardness is checked by weights (included
in the standard delivery range) which are added
until the suppository collapses. ERWEKA Suppository
Penetration Tester, Type
230V/50Hz 11-465-0001
230V/60Hz 11-465-0002 PM 30
115V/60Hz 11-465-0003
127V/60Hz 11-465-0004 Suppositories must dis-
integrate, dissolve or
melt at body tempera-
ERWEKA Suppository Melt- ture.
ing Point Tester, Type SSP The ERWEKA PM 30 is
designed to deliver re-
The SSP consists
producible results for
of a graduated tube
softening time of sup-
(test chamber). The
positories.
sample to be tested
The unit comprises of three glass test tubes
is placed in a spiral
each for 1g, an acrylic glass water bath and an
shaped glass test
immersion thermostat (1.500 Watts at 230V,
basket inside the
test chamber, 1.000 Watts at 115V, accuracy 0.5C). The
which is sur- water bath temperature is displayed by an im-
rounded by a water mersion thermometer.
heating tube. For
heating of the PM 30 acc. to EP App. A
water inside the heating jacket, ERWEKA offers 230V/50Hz 11-467-0001
an optional Circulation Heater, Type EST 2. 230V/60Hz 11-467-0002
115V/60Hz 11-467-0003
SSP 10-466-0000 127V/60Hz 11-467-0004

PM 30 ditto, but glass tubes acc. to

EP App. B
230V/50Hz 11-468-0001
230V/60Hz 11-468-0002
115V/60Hz 11-468-0003
127V/60Hz 11-468-0004

134
 ERWEKA Suppository
Options for PM Disintegration Tester,
Glass test tubes, 2g, with adaptor, for PM 30 Type ST 32
acc. to EP App. B 81-000-1001 The ST 32 is a basic
suppository disintegra-
Glass test tubes, 3g, with adaptor, for PM 30 tion tester and complies
acc. to EP App. B 81-000-1002 with the latest EP
specifications. The unit
Immersion thermometer with certificate (in- comes with 3 test sta-
stead of non-certificated immersion ther- tions, either located in-
mometer) 75-001-0003 side a thermostatically
heated 12 liter water
Water Stabiliser with colour indicator, bath.
1 bottle for 2 fillings 80-080-0002 The test stations are automatically turned 180
in adjustable intervals. ST 32 features an inte-
Spare part kit for PM 30 acc. to EP App. B, grated "high-power" flow-through heating sys-
comprising of glass test chamber with ac- tem (accuracy 0.2C) and internal tempera-
cessories 91-467-0000 ture sensor for temperature display. A USB
printer interface for documentation purpose is
included in the standard delivery range. Test
time and nominal bath temperature is entered
via the membrane keys. Current test time as
well as actual water temperature are shown on
clearly visible red LEDs.
On request, an alarm may be selected to sound
upon completion of the preset test time.

230V/50Hz 10-469-0001
230V/60Hz 10-469-0002
115V/60Hz 10-469-0003
127V/60Hz 10-469-0004

Options for ST 32
Water Stabiliser with colour indicator, 1 bot-
tle for 2 fillings 80-080-0002

Spare part kit for ST 32 comprising of sieves

(2), belt (1) and fuses 90-469-0000

135
ERWEKA Suppository IQ/OQ/PQ documents
Disintegration Tester, IQ/OQ/PQ Document SBT 65-465-9999
Type ST 35 IQ/OQ/PQ Document SSP 65-466-9999
IQ/OQ/PQ Document PM 30 65-467-9999
In contrast to IQ/OQ/PQ Document ST 32 65-469-9999
the ST 32, the IQ/OQ/PQ Document ST 35 65-470-9999
ST 35 comes
with each test
station located IQ/OQ/PQ tools
inside a 4 liter
glass vessel Stop watch 90-240-0003
(with optional Stop watch, certified 95-240-0003
magnetic stirrer) which are placed inside a Immersion Thermometer cert. 75-001-0003
thermostatically heated water bath (leak-free,
double secured). The test stations are automat-
ically turned 180 in adjustable intervals. ST 35
features an integrated "high-power" flow-
through heating system (accuracy 0.2C) and
internal temperature sensor for temperature
display. A USB printer interface for documenta-
tion purpose is included in the standard delivery
range. Test time and nominal bath temperature
is entered via the membrane keys. Current test
time as well as actual water temperature are
shown on clearly visible red LEDs.
On request, an alarm may be selected to sound
upon completion of the preset test time.

Due to the width, at the ST 35 the test stations

are separable to simplify the cleaning process.

Optional separately controllable magnetic stir-

rers can be placed in each test station (glass
beaker) to get the required hydrodynamics.

230V/50Hz 10-470-0001
230V/60Hz 10-470-0002
115V/60Hz 10-470-0003
127V/60Hz 10-470-0004

Options for ST 35
Set (3) of magnetic stirrers, controlled by the
membrane keys of the unit
10-470-500x

Water Stabiliser with colour indicator, 1 bot-

tle for 2 fillings 80-080-0002

Spare part kit for ST 35 comprising of sieves

(2), glass beaker (1), belt (1) and fuses
90-470-0000

136
All-Purpose-Equipment
1. Motors
1.1. AR 403 1.3. AMD
This Drive Unit features a 230V (single phase)
or 400V (three phase) asynchronous motor. It is
adjustable between 46 and 410 rpm by means
of a lockable hand wheel.

AMD
230V/50Hz (single phase) 10-503-0001
400V/50Hz (three phase) 10-503-0031
230V/60Hz (single phase) 10-503-0002
400V/60Hz (three phase) 10-503-0032
115V/60Hz (single phase) 10-503-0003
200V/60Hz (three phase) 10-503-0033

The sturdy ball bearing worm gear drive is Other voltage is available on request.
completely maintenance free and provides an
output torque of max. 30 Nm. The unit features
electronic speed control variable between 0 and Options for AR 403/-S and AMD
400 rpm.
The Speed is regulated by a digital dial. By a
Foot Switch for ON/OFF of the above men-
permanent nominal/actual adjustment the pre-
tioned motor drives 11-507-0000
selected speed is kept, even under varying
load.
AR 403 USB interface for print out
The AR 403-S is similar to the AR 403 but of-
80-503-0000
fers a different connection to the attachment.
This connection is designed for better transfer
IQ/OQ/PV documents AR 403/-S
of the torque. It can be used with some of the
66-503-9999
ERWEKA attachments.

Tolerance time: +/- 1 sec

Tolerance RPM: +/- 1 RPM

230V/50Hz 13-502-0001
230V/60Hz 13-502-0002
115V/60Hz 13-502-0003
127V/60Hz 13-502-0004

1.2. AR 403-S
The AR 403-S is similar to the AR 403 but of-
fers a different connection to the attachment.
This connection is designed for better transfer
of the torque. It can be used with some of the
ERWEKA attachments.

230V/50Hz 13-502-1001
230V/60Hz 13-502-1002
115V/60Hz 13-502-1003
127V/60Hz 13-502-1004

137
2. Attachments
Universal Gear, UG Homogeniser, HO/HHO

The ERWEKA Universal Gear is required for

adjustment of the operation angle and for speed
reduction. It is needed to operate the following
attachments: KB 15/20/S, PT, DKE/S and GTE. For oil-in-water or water-in-oil emulsions. The
mixing is done by compression by [Link] pis-
UG 10-508-0000 ton. The volume of the [Link] hopper is 1.5
litres. Max. output 30kg/h.

Three-Roller-Mill, SM/SMS HO (standard version) 10-509-0000

HHO (with heated hopper) 10-509-1000
HO/UA (circulation and filling unit)
80-509-0000

Planetary Stirrer, PRS

This attachment is suitable for the production of

ointments, pastes, crmes and similar pro-
ducts. The space between the rollers is adjust-
able by one screw. According to customers
requirements, the rollers can be delivered made
of porcelain or [Link]. An ideal mixer for crmes, ointments, pastes,
liquids and moist powders. Different [Link]
SM (rollers made of porcelain) 10-508-1000 mixing and kneading tools come with the unit.
SMS (rollers made of [Link]) 10-508-2000 The 5.0 litre hopper is made of [Link] and
offers a maximum capacity of 60%.
Optionally an electric heated vessel or a double
jacket vessel for heating and cooling by water is
available.

PRS 10-512-0000
DER (vessel with heater) 80-512-0000
DW (vessel with double jacket) 80-512-5000

138
Laboratory Kneader, LK5 Filling and Dosing Machine for
Liquids, FDF

Two position filling and dosing machine. Pre-

Two [Link] Z formed arms are rotating in cision dispensing, no-drip filling, easy adjust-
different direction in different speed to offer best ment of volume, quick removal of the dosing
mixing results. The container has a capacity of pumps and valves for cleaning, sterili-sation
5.0 litres with a max. capacity of 65%. and space saving tabletop design.
Optional the container is available with an elec- Max. Output 2.000 fillings/h.
tric heating jacket. Dosing pumps for 5 - 30 ml (DP 30) and 20 -
150 ml (DP 150) and filling nozzles in different
LK 5 10-514-0000 diameter are available.
LK 5/DER (heated container) 10-514-5000 The FDF is the basic unit without pumps.

FDF 10-516-0000
Suppository and Lipstick DP 30 (5-30 ml) 80-516-0010
Moulding Machine, SG 4/W DP 150 (20-150 ml) 80-516-0020
Filling Nozzles (2), 6 mm 80-516-0001
Filling Nozzles (2), 8 mm 80-516-0002

Filling and Dosing Machine for

Ointments and Crmes, FDS

For the moulding of suppositories, lipsticks and

similar products. The mixing vessel has a ca- For precision filling and dosing of ointments,
pacity of 5.0 litres with a max. capacity of 65% crmes, emulsions and similar products into
and can be electrically heated between 20C tubes, cans, bottles etc. The [Link] hopper has
and 100C. Stirring, mixing and melting is a volume of 19.0 litres. Standard dosing ranges
achieved in a single operation and are not inter- between 10 and 200 ml. Filling nozzles with 2, 4
rupted during the filling process. and 8 mm i.d. are delivered with the unit. Max.
capacity 1.200 fillings/h.
SG 4/W 10-515-0000 Optional dosing unit for filling and dosing of 0.5
Moulds on request to 25 ml and dispense heads with different ap-
ertures and special heads for filling tubes.

FDS 10-517-0000
Dosing 0.5 to 25 ml 80-517-1000
Dispense heads for tubes 80-517-2000

139
Ball Mills, KM Drum Hoop Mixer, RM

Drum Hoop Mixer with diagonal placement of

For grinding crystalline materials and for mixing
the drum within the hoop. The rotation of the
dry, or - under certain circumstances - moist
hoop itself produces an uniform, three dimen-
materials. The balls are made of porcelain hav-
sional displacement of the material to be proc-
ing a diameter from 30 to 50 mm. The drum is
essed and hence a tumbling mixing action. The
sealed air-tight with a lid and is delivered incl.
mixer comprises of two parts: drive support and
frame for drive unit. Drum and Balls can be
drum hoop with acrylic mixing drum. Drum is
sterilised in water.
delivered incl. frame for drive unit. For using the
For using the Ball Mill, a drive support is
Drum Hoop Mixer a drive support is needed,
needed, which is optional available lengthened
which is optional available lengthened for the
for the simultaneous use of two Mixers of the
simultaneous use of two Mixers of the same
same size (KM 5 or KM 10). The Drum is avail-
size (RM 5 or RM 10). Mixing drums with 5 and
able with either 5 or 10 litres volume.
10 litres volume are available.
KM 0 stainless steel for UG 10-518-0050
RM 5 (5.0 l volume) 10-519-0000
KM 5 (5.0 litres volume) 10-518-0000
RM 10 (10.0 l volume) 10-519-1000
KM 10 (10.0 litres volume) 10-518-1000
Spare vessel, 5.0 l 90-519-0000
KMD 5 (2x 5.0 litres volume) 10-518-2000
Spare vessel, 10.0 l 90-519-1000
KMD 10 (2x 10.0 litres volume) 10-518-3000
Spare drum, 5.0 l. 90-518-0500
Spare drum, 10.0 l. 90-518-1000
Spare set of balls 90-518-2000 Y-Mixer, YB 5

Double Cone Mixer, DKM

ERWEKA mixer YB 5 with Y-shaped mixing

vessel for the gentle mixture of solid well flow-
ing materials (bulk materials). The rotary motion
of the mixing vessel makes a particularly ho-
mogeneous mixture possible and is suitable for
sensitive materials. For optimal filling, emptying
For free flowing powders and granules. The
and cleaning the mixing vessel is equipped with
arrangement of the mixer in combination with
three capacious openings.
the angle adjustment of the Universal Gear
Volume of mixing container: 5 litres, recom-
allows a multi-dimensional mixing process. The
mended working conditions: max. 1.5 litres
11.9 l [Link] container has a working capacity
(30%) and 0 - 40 RPM.
of approx. 50%.
All parts coming into contact with the material
are made of stainless steel.
DKM 10-520-0000
10-527-0050

140
Vibration Sieve Shaker, VT
Reciprocating Sieve set compris-
cam system. The ing of 4 sieves (315
intensity of the m; 71 m; 1,25
shaking action mm; 2,0 mm MW)
can be adjusted acc. to ISO 9044,
by the speed of 20 cm diameter,
the motor drive. made of [Link],
Different sieve sets can be fitted to the sieve Type PS/S
shaker. 10-521-0000 80-521-0002

Cover made of stainless steel with collection

Sieve sets vessel (A+D), d=200 80-521-2310
Sieve set compris-
ing of 9 sieves Test Sieves made by stainless steel, version:
(Kresner) acc. to Soft-PVC-Welding, contains Sieve Frame Rd
DAB 1998, ISO 200x50, Sieve Mesh according to DIN4788,
9044 No. 0-8, 31 (Mesh 135 m 2,00 mm)
cm diameter,
made of Phosphor- Mesh 315 m 80-521-2315
bronce, Type VS Mesh 710 m 80-521-2710
80-521-0000 Mesh 1,25 mm 80-521-2125
Mesh 2,00 mm 80-521-2200
Sieve Inlays, Mesh of Stainless Steel Mesh DIN
4189 fixed with wire ring.
Coating Pan DKE/DKS
Mesh 180 m 80-521-0180
Mesh 250 m 80-521-0250 The Universal Gear at-
Mesh 355 m 80-521-0355 taches the Coating
Mesh 500 m 80-521-0500 Pans to the motor drive.
Mesh 710 m 80-521-0710 This allows adjusting
Mesh 1,40 mm 80-521-0140 the angle of the pan
Mesh 2,00 mm 80-521-0200 and getting an optimum
Mesh 2,80 mm 80-521-0280 result from the coating
Mesh 4,00 mm 80-521-0400 process. An infra red
radiator with fixing rod
Equal to 80-521-0000 but made of [Link], can be mounted above the pan to accelerate
Type VS/S 80-521-0001 drying if required.

Sieve Inlays, Mesh of Stainless Steel Mesh DIN DKE, [Link] pan, volume 9.5 l., max. capacity
4189 fixed with wire ring. 30%, 275 mm outside diameter 10-522-0001

Mesh 180 m 80-521-1180 DKS, [Link] pan, volume 15.0 l., max. capacity
Mesh 250 m 80-521-1250 30%, 350 mm outside diameter 10-522-0002
Mesh 355 m 80-521-1355
Mesh 500 m 80-521-1500 Infra red drying attachment 80-522-0000
Mesh 710 m 80-521-1710
Mesh 1,40 mm 80-521-1140 Spare bulb for above 90-522-0000
Mesh 2,00 mm 80-521-1200
Mesh 2,80 mm 80-521-1280
Mesh 4,00 mm 80-521-1400

141
Polishing Drum Dry Granulator, St. Steel,
TG 2000

Designed for polishing of coated tablets. The

interior of the drum is covered with inter-
changeable felt parts. The cover of the drum
has a 120 mm diameter opening for control of
the coating process as well as for adding pol- Two [Link] rollers equipped with teeth produce
ishing agent during the production process. To a powerful grinding action by forcing the mate-
connect to an ERWEKA motor drive, a Univer- rial against a series of breaking combs. Very
sal Gear, Type UG is needed. low proportion of fines (max. 25%) which can
even be reduced to about 15% by adjustment of
PT 10-523-0000 the slug making process. Max. capacity 20
kg/h.
Spare set of felt parts 90-523-0000
TG 2000 10-524-0000
Wet Granulator, FGS
Pelletiser, GTE
The Pelletiser is attached
to the motor drive via the
Universal Gear to be able
to adjust the angle. The
rotary movement of the
pan carries the product to
the top of the pan where-
The Wet Granulator operates on the oscillating upon it then flows down in
rotor principle by compressing the granules an even stream to the base whereupon the
through a sieve of a predetermined size. All process is repeated. By the addition of the req-
parts coming into contact with the product are uisite amount of liquid, this process can be con-
made of [Link]. The unit is supplied with verted into the formation of pellets. The pellet
sieves of 1.0 mm and 1.6 mm MW. Other size is chosen by the angle the pan is adjusted,
sieves are available on request. the amount of liquid added and the type of feed.
Max. capacity 30 kg/h. When the pan is full, the pellets will be continu-
ously rolled over the edge of the pan into a
FGS incl. standard sieves 10-525-0000 container. All parts coming into contact with the
Spare sieve 1.0 mm MW 90-525-0010 material are made of [Link].
Spare sieve 1.6 mm MW 90-525-0016
Sieve 300 m MW 80-525-0315 GTE 10-528-0000
Sieve 630 m MW 80-525-0630
Sieve 800 m MW 80-525-0800
Sieve 1.00 mm MW 80-525-1000
Sieve 1.25 mm MW 80-525-1250
Sieve 1.60 mm MW 80-525-1600
Sieve 2.00 mm MW 80-525-2000
Sieve 2.50 mm MW 80-525-2500
Sieve 3.15 mm MW 80-525-3150

Sieves with different MW can be supplied on

request according to customer specifications.

142
Cube Mixers, KB Conical Mill, CM 60/UD
Is a product in feed
system for applica-
tion for develop-
ment in pharma-
ceutical and food
industry which
comminute pow-
dery and free-
flowing products by
Mixing by tumbling action to produce homoge- a sieve (adjustable 0.3 3.0 mm; perforated
nous blend. Because of the gentle mixing action round holes, grater holes or square holes; see
the mixer may be used sensitive products. The list) with fixed maximum sizes of impurity-free
mixing action is assisted by three [Link] rods granule.
strategically positioned within the cube. The Rotation speed (continuous 60 1200
Cube Mixer is available in two sizes, made of revs/min) and sieve crack (standard 1.5 mm,
acrylic glass or [Link]. Max. capacity is 40% of adjustable 0.5 3.0 mm in 0.25 mm steps) can
the total volume of the cube. be varied for detailed adjustment of process.
A Universal Gear is needed to attach the Cube 10-527-0000
Mixer to the motor drive in order to be able to
change the angle. Options
KB 15, made of acrylic glass, 3.5 l volume Material certificate for all product contacting
10-526-0015 parts 85-527-9999
KB 15 S, made of [Link], 3.5 l volume Rotor type I (square shaped impeller bars)
10-526-1015 80-527-0100
KB 20, made of acrylic glass, 8.0 l volume Rotor type IV (round shaped impeller bars)
10-526-0020 80-527-0200
KB 20 S, made of [Link], 8.0 l volume Rotor type V (slanted impeller bars)
10-526-1020 80-527-0300
KB 30 made of acrylic glass, 11 l volume Rotor type VI (small shovel type impeller
10-526-0030 bars) 80-527-0400
KB 30 S made of st. steel, 11 l volume Rotor type VII (quarter-circle shaped impel-
10-526-1030 ler bars) 80-527-0500
Rotor type VIII (a large shovel type impeller
bars) 80-527-0600
High Speed Mixer, SW 1/S
Sieve/screen inserts
Round holes RL 0,5 mm
80-527-1000
Round holes RL 0,6 0,8 mm
80-527-2000
Round holes RL 1,0 1,4 mm
80-527-3000
Round holes RL 1,5 2,5 mm
Drum mixer operating on the plough-share prin-
80-527-4000
ciple and designed to mix powders, granules
Friction holes RR 1.0 1,2 mm
and other products of a fibrous nature. Quantity
ratios of 1:100.000 can be mixed homoge- 80-527-5000
nously in just a few minutes. The mixing drum Friction holes RL 1,5 2,5 mm
has a removable cover and can rotate through 80-527-6000
Friction holes RR 3.0 mm
180 degrees for loading and emptying. All parts
80-527-7000
coming into contact with the material are made
of [Link]. Square holes QL 1,5 2,5 mm
The mixing drum has a volume of 5.0 l and a 80-527-8000
max. capacity of approx. 70%.
SW 1/S 10-530-0000

143
Tablet Presses
Single Punch Tablet Press, Options for Tablet Press,
EP-1 Type EP-1
Measurement and display of compression
force 72-xxx-1xxx

Data transfer option RS 232 interface

72-531-0006

Data logging Software 72-531-0005

Standard data export via RS232 interface

82-531-0001

Support table in stainless steel; H/D/W

(mm): 750/600/800 82-531-0004

Single punch and die set, 4.0 mm to 20.0

mm diameter, Type STR 1, for round tablets
72-531-0001

Single punch and die set, 4.0 mm to 20.0

mm diameter, Type STS 1, for shaped tab-
lets 72-531-0002
The single punch eccentric Tablet Press EP-1
can manufacture tablets and odd shaped prod- Development of STR 1 or STS 1
ucts with a diameter of up to 20mm. It operates 72-531-0003
automatically i.e. the die is filled, the material
compressed and the tablet ejected continu- IQ/OQ documents 65-531-9999
ously. The compression force of up to 3 tons
and the filling depth of up to 15mm are easy to Transformer for EP-1 (from 110V to 230V)
adjust. All components are either covered with 72-531-2007
hard chrome, or made of stainless steel AISI
316 or acrylic glass for the front door. The
throughput is max. 4.000 strokes per hour.

EP-1 72-531-0000

Technical Data EP-1:

Press speed is infinitely variable
Max tablet diameter 20mm
Max filling depth 17mm
Max compression force 3t
Max tablet output 4000 tablets/hour
Net weight 135kg
Dimensions Press L/W/H (mm)
425/385/640
Dimensions with attachment parts L/W/H
(mm) 550/400/800
Power supply 230V/50-60Hz
Electrical load 2,2 kVA

144
16-Station Rotary Tablet Options for TR-B 16
Press ERWEKA TR-B 16
Set (18) of round tooling, diameter to be
agreed 80-532-0001

Set (18) of shaped tooling (oblong, oval),

length/diameter to be agreed
80-532-0002

Set (18) blind Dies 80-532-0003

Open Die Feeder 70-532-xx1x

Level Control Sensor in Hopper

80-532-0005

Support Table in stainless steel

80-532-0004

Table top GMP tablet press with 16 stations for

production of up to 38.400 tablets/hr (effective
production = 70 % max. production), Tooling
type EU B (IPT).
All machine settings set by hand-wheels with
position indicator at the front of the unit.
Three-phase motor with variable speed (In-
verter). Main gear box in oil-bath.
The unit comes with Rotary Force Feeder (vari-
able speed) and Pre-Compression station with
Rollers as standard.

16 stations
Tooling EU (IPT) B
For round and shaped tablets
Max. Diameter 18 mm,
18 mm x 9 mm for shaped tablets
Max. Filling Depth 17 mm
-1
Die Table 10 - 40 min
Die Table Stainless steel (1.2530)
O-ring punch seals for upper sleeves
Turret with keyways in upper guides
Output up to 38.400 samples/hr.
Max. Compression force 40 kN
Max. Pre-Compression force 6 kN
Upper punch penetration 3 mm
Voltage 380 3 Ph 50 Hz
H/D/W (mm): 1200/460/670
Net weight: 380 kg

380V/3-phase 50Hz 70-532-0001

230V/2-phase 50Hz 70-532-0002

145
8-Station Rotary Tablet
Press ERWEKA TR-D 8
Options for TR-D 8

Set (8+2) of round tooling, diameter to be

agreed 80-533-0001

Set (8+2) of shaped tooling (oblong, oval),

length/diameter to be agreed
80-533-0002

Set (10) Blind Dies 80-533-0003

Open Die Feeder 70-533-xx1x

Level Control Sensor in Hopper

80-532-0005

Table top GMP tablet press with 8 stations for

production of up to 19.200 tablets/hr (effective
production = 70 % max. production), Tooling
type EU D (IPT).
All machine settings set by hand-wheels with
position indicator at the front of the unit.
Three-phase motor with variable speed (In-
verter). Main gear box in oil-bath.
The unit comes with Rotary Force Feeder (vari-
able speed) and Pre-Compression station with
Rollers as standard.

8 stations
Tooling EU (IPT) D
For round and shaped tablets
Max. Diameter 25 mm,
22 mm x 10 mm for shaped tablets
Max. Filling Depth 17 mm
-1
Die Table 10 - 40 min
Die Table stainless steel (1.2530)
O-ring punch seals for upper sleeves
Turret with keyways in upper guides
Output up to 19.200 samples/hr.
Max. Compression force 40 kN
Max. Pre-Compression force 6 kN
Upper punch penetration 3 mm
Voltage 380 3 Ph 50 Hz
H/D/W (mm): 1200/460/670
Net weight: 380 kg

380V/3-phase 50Hz 70-533-0001

230V/2-phase 50Hz 70-533-0002

146
Accessories and Instrumenta-
tion of TR-B 16/TR-D 8
Device for upper compression force meter
and recorder (upper roller). Strain-gauge
load cell fitted in the shaft, which supports
the upper compression roller (complete with
single amplifier) to be connected to com-
puter with software 75-532-0001

Device for lower compression force meter

and recorder. A strain-gauge load cell fitted
under the ejection cam (complete with single
amplifier) to be connected to computer and
software 75-532-0003

Device for upper pre-compression force

meter and recorder (upper roller). Strain-
gauge load cell fitted in the shaft, which
supports the upper compression roller (com-
plete with single amplifier) to be connected
to computer with software
75-532-0004

Device for upper and lower punch position

and displacement and recorder (upper
roller).Strain-gauge load cell fitted in the
shaft, which supports the upper compression
roller (complete with single amplifier) to be
connected to computer with software
75-532-0005

Device for ejection force meter and recorder.

A strain-gauge load cell fitted under the
ejection cam (complete with single amplifier)
to be connected to computer and software
75-532-0002

Windows based software to analyse the

above mentioned forces. Complete with in-
terface board, cables and triggering device
(for IBM compatible computers, from Pen-
tium 233) 51-532-0000

Electric Switchboard ([Link]) including

computer and printer for positioning of ampli-
fier boxes, computer and printer (please
note that the parts can also be placed on a
table) 76-532-0004

Calib. Kit to calibrate press strain gauge

85-532-0001

Documents for Tablet Press Qualification;

IQ/OQ/PQ documents, IQ documents are
filled 65-532-5999

147
ERWEKA Roller Compactor Options
IQ/OQ/PQ document for Roller Compactor
66-456-9999

Band screw stirrer for processing light bulk

density material 80-456-0100

Spare compactors rolls compactor surface

smooth 80-456-0101

Spare compactors rolls compactor surface

grooved 80-456-0102

Spare compactors rolls compactor surface

knurled 80-456-0103

Spare screen insert for rotor sieving mill

80-456-0200

Start up Assistance, commissioning and

service 80-456-0000

RCC 100x20 Pharma

Roller Compactor for dry granulation which turn

powder into granules within seconds. This ma-
chine is especially designed to cater for fre-
quent product changes and to work with small
quantities of product, like 10 - 20 g batches.
With a maximum throughput capacity of up to
10 kg/h this machine can also used for small
scale production.
This Roller Compactor features a new compo-
nent exchange system for easy cleaning and
maximum flexibility is mobile and has an inte-
grated control system. It is operated by a user
friendly touch panel.
Results observed could be scaled up to produc-
tion machines.

230V/50Hz 13-456-0001
230V/60Hz 13-456-0002
115V/60Hz 13-456-0003
127V/60Hz 13-456-0004

148
ERWEKA Fluid Bed System Options
FB-05 Mobile undercarriage to place the FB-05.
Table approximate dimensions: width/
depth/height: 1000mm/800mm/900mm
80-602-0005

Micro-Kit. Micro-Kit can be used for granulat-

ing and coating. Minimum batch sizes of 2,5
50 g can be processed. It consists of ex-
pansion chamber with gravity feed charge
portand pneumatically actuated vibrator,
control unit for vibrator, filter plate with filters,
product container with one gauge connec-
tion for optional temperature probe, bottom
plate with vertically adjustable spray nozzle,
spray nozzle 0,3mm, hose system including
small hose nozzle for minimal spray rates.
80-602-0006

The very compact FB-05 has been designed Peristaltic pump to transport the spray liquid
for drying, granulating and coating of quantities from a spray medium tank to the spray noz-
from 50 to 750 ml (optional from 5 to 100 ml, zle. Used by granulating and coating.
see also Micro-Kit). 80-602-0007
Special care has been taken to offer easy han-
dling and fast cleaning to make this unit the Temperature measurement instrument with
ideal partner for use in research and develop- digital display. It can be used alternatively
ment departments. for one of both gauge connections.
This advanced fluid bed offers perfect flow 80-602-0008
properties to be able to work even with difficult
products in very small batch sizes. The unique Expansion chamber made of borosilicate
spay nozzle has been developed to work with glass instead of Plexiglas (solvent resistant)
very small quantity of product. Outlet air is fil- 80-602-0009
tered by metal filter cartridges. All parts which
come in contact with the product are made of Spray nozzle insert, 0,3mm 80-602-0010
high-grade steel (AISI-316L).
Spray nozzle insert, 0,8mm 80-602-0011
230V/50Hz 71-602-0001

Technical data contained herein (including, Recommended spare parts

without limitation, weight and measurement
indications) are issued for the sole purpose of Basic package, including O-rings and seal-
giving an approximate value, unless they are ings 94-602-0000
expressly referred to as binding in the order
confirmation. Package for Micro-Kit, including O-rings
94-602-0001
Container volume: 750ml
Power consumption: 3000 W
Working pressure: 4-6 bar flow pressure
Required quality: oil, water and particle free
remaining humidity < 5.5 g/m filtered: 0,1
m Remaining oil content < 1 mg/m
Air power volume flow range: 30 -60 Nm/h,
max. 100Nm/h (depending on prod-
uct/process insert)
Exhaust air filter: cartridge filter with a theo-
retical mesh size of 10 m
Net Weight of unit: 90 kg
Dimensions: width/ depth/ height: 600 mm/
700mm/ 860 mm

149
Universal Automated
Documentation for all kind
of Rotary Tablet Presses

Automated Quality Control

For automated Quality Control the TRB 16/TRD
8 as well as any other tablet press wit single- or
double outlet can be connected to the
ERWEKA MultiCheck by an automatic Switch
and a Vacuum Transport System.
At the Windows based AutoDoc software the
interval for withdraw of the tablets from the tab-
let press, transport to the MultiCheck and the
number of samples to test is [Link] tab-
lets are separated (by TabSelect), transported
(by a Venturi Transport System), inserted into
the MultiCheck and than automatically tested
for weight, thickness, diameter and hardness.
The results are stored at the PC. Results, sta-
tistics and trend analysis can be displayed or
hard-copied by a connected printer.

Dedusters
Different Dedusters are available for TRB 16
and TRD 8. Please contact our Sales Depart-
ment for information.

Please contact us with your specifications.

230V/50Hz 10-600-0001
230V/60Hz 10-600-0002
115V/60Hz 10-600-0003
127V/60Hz 10-600-0004

150
Blister Density Checker
Options for VDT/S
ERWEKA Vacuum Density Upgraded electronic with USB printer inter-
Tester, Type VDT/S face for documentation of the test procedure
11-630-1xxx

Qualification Tool Kit for VDT/S comprising

of:
- Vacuummeter Type DVR
- Stop Watch 90-630-0000

Qualification Tool Kit, certified, for VDT/S

comprising of:
- Vacuummeter Type DVR
- Stop Watch 95-630-0000

IQ/OQ/PQ Documents 66-630-9999

To verify the function of blister packaging ma- Spare Part Kit 92-630-0000
chines ERWEKA offers the Vacuum Blister
Density Tester, Type VDT/S.
The unit is equipped with an integrated vacuum
pump.
Pressure (-200 mbar and -850 mbar, dependant
on weather condition and size of container) and
time (up to 99 min., 59 sec.) are adjustable by
the membrane function keys. The two bright LE
displays show remaining test run-time and ac-
tual pressure.
The blister is placed in the external pressure
container, which is filled with liquid. Different
sizes of containers are available.

ERWEKA VDT/S Blister Density Tester,

100V 240V, 50 and 60Hz with Pressure
Container 150 mm, including porcelain in-
sert for holding the blister 11-630-0000

ERWEKA VDT/S Blister Density Tester,

100V 240V, 50 and 60Hz with Pressure
Container 200 mm, including porcelain in-
sert for holding the blister 11-63x-1xxx

ERWEKA VDT Blister Density Tester, 100V

240V, 50 and 60Hz with Pressure Con-
tainer 250 mm, including porcelain insert
for holding the blister 11-63x-2xxx

ERWEKA VDT Blister Density Tester, 100V

240V, 50 and 60Hz with Pressure Con-
tainer 300 mm (glass), including porcelain
insert for holding the blister 11-63x-3xxx

151
Metered Dose Inhalers (MDI's)
ERWEKA Type Dosage Unit Andersen Type Cascade
Sampling App. DUSA-MDI Impactor, App. 1
The "Andersen" Type
Multi-Stage Cascade Im-
pactor Type ACI-MDI 1000
has been designed for de-
termining the particle size
(aerodynamic size distribu-
tion) of Metered Dose In-
halers (MDI's) in accor-
dance with the specifica-
tions as laid down in USP
The ERWEKA Type Dosage Unit Sampling and EP.
App. DUSA-MDI has been designed for the The unit is available in two versions for opera-
sampling and testing of pressurised Metered tion at 28,3 litres per minute or 60 litres per
Dose Inhalers (MDI's). It is used to perform minute.
those tests specified by the relevant compen-
dial standards, namely, "Total Number of Dis- Andersen Type Cascade Impactor, 23,8
charges per Container or Inhaler", "Dose Uni- litres made of Aluminium 70-902-0001
formity" and "Dose Uniformity Over the Entire Andersen Cascade Impactor, 23,8 litres
Contents" as well as those tests designed to made of stainless steel 70-902-0002
simulate the performance of the inhaler during
actual use. 70-901-0001 Andersen Type Cascade Impactor, 60 litres
made of Aluminium 70-902-0011
Andersen Cascade Impactor, 60 litres made
Base Plate including Clamps of stainless steel 70-902-0012
80-901-0001
Unit is delivered excl. filters!
Pack (100) Filters, 1 micron, 47 mm diam.
80-906-0000 Options
Unit is delivered excl. filters! Universal Induction Port, Aluminium
80-902-2001
Universal Induction Port, stainless steel
80-902-2002
60 litres conversion kit, Aluminium
80-902-6001
60 litres conversion kit, stainless steel
80-902-6002
90 litres conversion kit, Aluminium
80-902-9001
90 litres conversion kit, stainless steel
80-902-9002
Certificate of compliance 85-905-9999
Pack (100) Filters, 81 mm, 0,7 micron
80-902-0000
Pack (100) Filters, 81 mm, 1,4 micron
80-902-0001

152
Dry Powder Inhalers (DPI's)
ERWEKA Type Dosage Andersen Type Cascade
Unit Sampling App., Impactor, App. 3
Type DUSA-DPI The "Andersen" Type
Multi-Stage Cascade Im-
pactor has been designed
for determining the parti-
cle size (aerodynamic size
distribution) in accordance
with the specifications as
laid down in USP and EP.
The unit is available in two
versions for operation at
28,3 litres per minute or
60 litres per minute. A Preseparator is inter-
The ERWEKA Type Dosage Unit Sampling posed between the Induction Port and Stage 0
App. for DPIs has been designed for the sam- of the apparatus in order to collect large
pling and testing of Dry Powder Inhalers. It is masses of non-inhalable powder prior to their
used to perform those tests specified by the entry into the impactor.
relevant compendial standards, namely, "Total
Number of Discharges per Container or In- Andersen Cascade Impactor and Presepera-
haler", "Dose Uniformity" and "Dose Uniformity tor, 28,3 litres, made of aluminium
Over the Entire Contents" as well as those tests 70-909-0001
designed to simulate the performance of the
inhaler during actual use. 70-906-0001 Andersen Cascade Impactor and Presepera-
tor, 28,3 litres made of stainless steel
70-909-0002
Base Plate including Clamps
80-901-0001 Andersen Cascade Impactor and Presepera-
tor, 60 litres, made of aluminium
Pack Filters (100) for Type DUSA-DPI, 70-909-0011
1 micron, 47 diameter 80-907-0000
Andersen Cascade Impactor and Presepera-
Unit is delivered excl. filters! tor, 60 litres made of stainless steel
70-909-0012

Unit is delivered excl. filters!

Options for Type ACI-DPI 1000

Universal Induction Port, aluminium
80-902-2001
Universal Induction Port, stainless steel
80-902-2002
60 litres conversion kit, Aluminium
80-902-6001
60 litres conversion kit, stainless steel
80-902-6002
90 litres conversion kit, Aluminium
80-902-9001
90 litres conversion kit, stainless steel
80-902-9002
Certificate of compliance 85-905-9999
Pack (100) Filters, 81 mm, with open
centres 0,7 micron 80-909-0000
Pack (100) Filters, 81 mm, with open
centres 1,4 micron 80-909-0001

153
ASTRA Draco Multi-Stage Single Stage Glass Impac-
Liquid Impinger (MSLI), tor Glaxo (EP App. A)
Type ALI 1000
The Astra Draco Type
Multi-Stage Liquid
Impinger (MSLI) is a
versatile five stage
cascade impactor,
which can be used for
determining the parti-
cle size (aerodynamic
size distribution) of
inhalers. The unit operates on the principle of liquid im-
pingement to divide the dose emitted from the
inhaler into the non-respirable dose impacting
on the mouth and oropharynx wich is swallowed
and the remaining respirable dose.
Multi-Stage Liquid Impinger made of Alumin- The apparatus is relatively simple, easy to use
ium 70-905-0001 and rugged in construction and is ideal for rou-
tine Quality Control applications. The Glass
Multi-Stage Liquid Impinger made of Single Stage Impactor comes complete with
stainless steel 70-905-0002 base plate and appropriate clamps, bossheads
and fittings as standard. 70-907-0001
Universal Induction Port, Aluminium
80-902-2001 Options
Universal Induction Port, stainless steel Special Modification for nasal sprays
80-902-2002 80-907-0001
Certificate of compliance 85-905-9999
Single Stage Metal
Unit is delivered excl. filters!
Impinger Fisons
Options (EP App. B)
Filter for Type Astra (MSLI)
80-905-0000

The principle of operation is similar to that of

the glass impinger in that the unit splits the
aerosol cloud into the respirable fraction that
effectively passes through to the final filter
stage and the non-respirable fraction that is
trapped in either the throat or on the sintered
glass disc of the stage plate. The Metal Single
Stage Impinger comes complete with base
plate and appropriate clamps, boss heads and
fittings as standard. 70-908-0001

154
Inhaler Accessories ERWEKA Vacuum Pump
Type VP 1000
Testing Unit for Dry Powder
Inhalations, Type TP-DG-
DPI 1000

The ERWEKA Vacuum Pump VP 1000 used for

testing MDI's and DPI's employs a Rotary Vane
Vacuum Pump rated at 250 litres/min. free air
In case of Dry Powder Inhalers (DPIs), both the
(210 Litres/min. when used with the control
emitted and fine particle dose are affected by
valve). The unit is supplied complete with an
the strength and duration of the patient's in-
Electronic Digital Flow Meter as standard.
spiration. Furthermore, different inhalers pro-
The air-flow is adjusted by means of the screw
vide varying degrees of resistance to inhalation.
valve on the front of the pump. The screw valve
It has been established that the standardised
itself creates a restriction to the air flow such
testing of Dry Powder Inhalers is dependent on
that the maximum flow rated achievable is ap-
a number of factors:
proximately 210 litres/min.
1. The pressure drops of the air drawn over the
ERWEKA Vacuum Pump, Type
inhaler during inspiration
VP 1000, incl. Flow Meter
2. The appropriate flow rate (Q) to give a pres-
70-910-0001
sure drop of 4kPa.
3. The duration of in-vivo inspiration to give a
volume of 4 litres
4. Flow rate stability in terms of critical (sonic)
flow

The "General Control Equipment" for DPI's

specified in USP and "Experimental Set Up" for
testing specified in EP take all of these theoreti-
cal factors into account.
The main features of the Critical Flow Control-
ler are as follows:

Built in Differential Pressure Meter for

measuring pressure drop (P1)
Flow Adjustment valve to adjust flow rate
Timer controlled two-way solenoid valve to
adjust flow duration
Absolute Pressure Meters for measuring
sonic flow (P2 and P3)
Membrane keypad control
LED display of differential and absolute
pressure valves
Illuminated LC display of Set and Elapsed
Times
Printer port

Critical Flow Controller, TP DG- DPI1000

70-913-0001

155
ERWEKA High Power Digital Flow Meter Type
Vacuum Pump, HVP DFM Stand Alone Unit
The standard pump VP 1000 rated at 250 li-
tres/min free air (i.e., with nothing attached to
it). However, this flow rate can fall dramatically
when the resistance of both test device and
inhaler are taken into account.
For tests where the flow-rate of the standard
pump is not enough to create a Sonic-Flow a
second High-Power version of the ERWEKA
Vacuum Pump, Type HPV, is available. This
Rotary Vane Vacuum Pump rated at 460 li-
tres/min free air.
The Digital Flow Meter has been especially
Basically, there are two factors that govern the designed for use with the instrumentation em-
ability of a particular pump to achieve sonic flow ployed in testing pharmaceutical inhalers. Main
features of the DFM are: highly visible digital
1. The maximum capacity (air-flow) of the
LED readout direct in litres/minute, printer port
vacuum pump
and range 20-120 litres/minute. Full calibration
2. The resistance to that air flow provided by
certificate supplied with each unit.
the test device (Andersen, MSLI etc.) and
the inhaler itself Digital Flow Meter - Stand Alone
70-912-0001
ERWEKA High-Power Vacuum Pump, Type
HPV, incl. Flow Meter 70-910-0002

156
Options Inhaler
Leak Test Kit
IVIS Stage Mensuration
All impactors should be periodically tested to
check that there is no external leakage. Exces- Stage Mensuration to check the jets on
sive leakage of air from an impactor can result Andersen or Andersen Type Cascade Im-
in the incorrect flow rate being achieved, poor pactor stages from 5.5 down to 0.2 mm in
aerodynamic performance and possible loss of diameter (Hole Diameter Inspection with
drug. Report)
Leak testing is a simple and effective means of
checking that all the impactor components are 220-240V/50Hz 70-918-0001
assembled correctly and that there is no critical
wear associated with the inter-stage seals. Stage Mensuration (Hole Diameter Inspec-
tion with Report) including 1 Set of new O-
Rings 70-918-0002

Manual cleaning and rodding of the Impac-

tor 70-018-0003

Inhaler Software Programme

50-900-0000

IQ/OQ/PQ handbook 66-9xx-

9999

The Leak Test Kit provides a fast and effective Carrying Cases
means of running a health check on the impac-
tor. Simply connect the leak check system be- Carrying Case for Andersen Type
tween a suitable vacuum pump and the impac- 80-902-0002
tor - the leak test takes approx. 60 seconds.
70-915-0001 Carrying Case for ASTRA MSLI
80-905-0002
Leak Test Kit with all tools in certified ver-
sion 70-920-0001

Mouth Piece Adaptors

Standard Mouthpiece Adaptor, Type A
80-910-0001

Standard Mouthpiece Adaptor, Type B

80-910-0002

Special Mouthpiece Adaptors customised to

particular Inhalers are available on request.
Their purpose is to provide an airtight seal be-
tween the mouth of the test apparatus and the
inhaler being tested.

Special Mouthpiece Adaptor, Type A

80-916-0001

Special Mouthpiece Adaptor, Type B

80-916-0002

Spare canister 80-917-0001

157
Services Qualification/Qualification
ERWEKA offers Installation Qualification (IQ),
Installation Operation Qualification (OQ) and Performance
Verification (PV) documents for all its testing
Installation of most ERWEKA units (TA/R, TDR, units.
SVM, ZT, TBH or DT) is easy and can be These documents allow the user to validate/
achieved by the user himself or an engineer of qualify the equipment independently by follow-
the company. ing the instructions and filling in the attached
forms.
For more sophisticated products such as Disso- To outsource the Qualification/Qualification
lution Systems ERWEKA offers complete tubing procedure, ERWEKA offers installation as well
kits and even pre-configuration. The user or the as Operation Qualification and Performance
engineer has to connect the tubing and plug the Verification (IQ/OQ/PV) services on site. Our
numbered interface cable in the equivalent trained Service performs the complete
numbered sockets only. IQ/OQ/PV for you as well as training the users
to operate the equipment. This service ensures
For a perfect installation and training of the perfect installation and worry free operation.
user/s, ERWEKA offers a complete installation
service by an ERWEKA engineer. This means ERWEKA also offers Performance Qualification
the unit or system will be installed at your site, (PQ). Our trained engineers will carry out the
the operation will be checked and the user/s PQ test according to your requirements. This
receive a training in the operation of the unit action can even take place on the weekend not
and (when needed) software. to interrupt your normal laboratory work!

For Qualification Qualification Tool kits (non-

certified or certified) are available from
ERWEKA specially designed for each unit.
These Qualification Tool Kits comprise all nec-
essary tools for re-qualification of the unit.
When purchasing a calibrated tool kit most of
the tools have to be recalibrated each year.
This procedure can be done by the purchaser
or by ERWEKA (Calibration Tool Service).

With the new generation of Dissolution Tester,

ERWEKA offers the next step. The units are
equipped with Qualification-/calibration- and
service interval displays. The user is reminded
to re-qualify the unit after the USP/EP and FDA
proposed interval (6 months). As an option, the
units check the OQ automatically during the test
run and monitors mistakes on the standard OQ
traffic light. For Operation Qualification (OQ)
no papers have to be filled in! The results of the
System Suitability Test are entered by the key-
pad of the unit, a System Suitability Test print-
out is created by the unit.

158
Calibration Maintenance
Before shipping all ERWEKA Hardness- and To ensure a long lifetime for your units
Combination Testers as well as all electronic ERWEKA recommends regular maintenance.
temperature sensors are calibrated. The cali-
bration documentation comes with the unit. Dissolution Testers of the new generation are
equipped with a Service Interval Display, which
For re-calibration ERWEKA units come with a reminds the user every 3.000 hours of opera-
calibration menu in the standard firm-ware. On tion (stirring action), that maintenance is rec-
some of the equipment the calibration menu is ommended.
password protected to assure that only qualified
staff can re-calibrate the unit. Maintenance contracts are available. Our well-
trained service engineers perform the mainte-
For perfect operation and assurance of accu- nance.
rate results, ERWEKA offers Calibration Ser-
vices on site by trained ERWEKA Service Man-
agement staff. All calibration tools used by
ERWEKA are constantly checked. Certificates
Leasing
can be shown before the calibration procedure
takes place. Not to invest capital ERWEKA offers leasing of
its equipment in co-operation with well-known
For Tablet-Hardness Testers ERWEKA now international banks.
offers a dynamic Calibration Tool which allows
calibration of the electronic load cell without Leasing is normally possible from a purchasing
weights! The so-called AutoCal System uses a amount of approx. 10.000,00.
certified external load cell and (optionally) cali-
bration software for easy and more accurate
calibration within max. 5 minutes. In addition Used Equipment
the unit will be calibrated at up to 50 points
within the measuring range for assurance of ERWEKA also buys and sells used equipment.
results throughout the testing range. Results of When purchasing new ERWEKA equipment
calibration can be printed out and/or stored by ask, maybe we are interested to take back your
the computer. previous unit.
The system can be bought for self-calibration or
be used when having a calibration con-tract. These units will be completely refurbished, not
just painted!
Re-calibration contracts are available either
monthly, every 3 months, every 6 months or So when you need good equipment but your
once a year. budget is limited, ask for used equipment.

159
 Dissolution Testing General Information

Major organizations and groups that influence disso- Official Methods of Dissolution Testing and the cor-
lution testing standards in the US: responding ERWEKA equipment:

In the United States, Dissolution testing for pharmaceuti- United States Pharmacopoeia: USP XXVI (26)
cal products in tablet and capsule form is required by the European Pharmacopoeia: [Link] 7 th Edition
US Food and Drug Administration (FDA). The standards British Pharmacopoeia: BP
for testing are put by the US Pharmacopoeia (USP). Japanese Pharmacopoeia
Testing procedures are described in USP general chap-
ters under Dissolution <711> and Drug Release <724>. USP Apparatuses:
These standards offer different test apparatuses to use
according to the nature of the dosage form. USP Apparatus 1: Rotating Basket
USP Apparatus 2: Paddle
U.S. Pharmacopeia (USP) USP Apparatus 3: Reciprocating Cylinder
The United States Pharmacopeia (USP) is a nongovern- USP Apparatus 4: Flow-Through Cell
mental, standards-setting organization that advances USP Apparatus 5: Paddle over Disc
public health by ensuring the quality and consistency of USP Apparatus 6: Rotating Cylinder
medicines, promoting the safe and proper use of medica- USP Apparatus 7: Reciprocating Holder
tions, and verifying ingredients in dietary supplements.
USP provides standards for more than 4,000 prescription ERWEKA Dissolution Testers for USP apparatus 1
and non-prescription drugs, dietary supplements, veteri- (Basket), 2 (Paddle), 5 (Paddle over Disc) and 6 (Ro-
nary drugs and health care products. These standards tating Cylinder) are available in 2 standard versions,
are published in the United States Pharmacopeia and namely DT DT 720 and DT 820 series with 8
National Formulary (USPNF). [Link]. USP/[Link]. vessels (1.000 ml or 2.000 ml volume)
and 6, 7 or 8 test stations (stirrers).
US Food and Drug Administration (FDA) Most ERWEKA Dissolution Testers are available in 2
The FDAs major contribution to dissolution testing is its versions, "Low-Head" for easy manual sampling as well
issuance of numerous documents titled Guidance for as automated sampling and low evaporation (max. 0.3%
Industry that describe how to apply the similarity factor. within 24 h at 37.0C) and "High-Head" for maximum
The similarity factor is used to compare the dissolution access to the vessels during the complete test run.
profiles of different batches to assess or establish bio- Special versions with 3 test stations of 4.000 ml and 1 test
equivalence. station of 1.000 ml (reference) as well as Dual Dissolution
The FDA co-sponsors many workshops (e.g. from AAPS) Testers with 16 USP/[Link]. vessels and 12 or 14
and conferences on current regulatory issues. test stations (stirrers) can be supplied.
[Link].
ERWEKA Flow-Through-Cell Dissolution Testers for
Fdration Internationale Pharmaceutique (FIP) USP apparatus 4 are specifically made for those prod-
FIP is a world-wide federation of national pharmaceutical ucts which require long term tests (i.e implants) and
(professional and scientific) associations, which has a products which need a high amount of media volume to
mission to represent and serve pharmacy and pharma- dissolve (see page 72).
ceutical sciences around the globe. FIP spearheaded the
writing of the Guidelines for Dissolution Testing of Solid The perfect unit for multiple media change is the
Oral Products. The guidelines were published as a joint CALEVA BIO-DIS which complies with USP apparatus
report with Canadas Official Laboratories and Medicines 3 and optional apparatus 7.
Control Services and FIPs Section of Industrial Pharma- It is the perfect equipment for multiple pH change due to
cist. The main focus of the FIP Dissolution Working Group the 6 rows of vessels, 6 test stations and 2 Reference
is to provide a forum for discussion of dissolution issues Positions each, located in a thermostatically heated water
and to train dissolution analysts. The working group has bath.
sponsored and held many training workshops on dissolu-
tion testing. Workshops were held in Vietnam and in
[Link] equipment was made available by
ERWEKA on both workshops.
Homepage: [Link].

American Association of Pharmaceutical Scientists

(AAPS)
AAPS is a professional, scientific society of more than
10,000 members employed in academia, industry, gov-
ernment and other research institutes worldwide. The
AAPS sponsors many short courses, workshops, and
conferences dedicated fully or in part to dissolution test-
ing.

160